Senior Pharmaceutical Quality Control Analyst

80100 Nairobi, Nairobi KES220000 Annually WhatJobs remove_red_eye View All

Posted 19 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company committed to developing high-quality medicines, is seeking an experienced Senior Pharmaceutical Quality Control Analyst to join their state-of-the-art remote team. This position offers the flexibility to work from anywhere, contributing vital expertise to ensure the efficacy and safety of our client's pharmaceutical products. The ideal candidate will possess a deep understanding of analytical techniques, regulatory compliance, and quality management systems within the pharmaceutical industry. You will be responsible for performing a wide range of analytical tests on raw materials, in-process samples, and finished products, meticulously documenting results and identifying any deviations from quality standards. Your role is critical in upholding the rigorous standards required for drug manufacturing and distribution, ensuring compliance with global regulatory bodies. This is an excellent opportunity for a detail-oriented professional to make a significant impact on public health.

Responsibilities:
  • Perform complex analytical testing on pharmaceutical raw materials, intermediates, and finished products using various techniques such as HPLC, GC, UV-Vis spectrophotometry, and Karl Fischer titration for projects supporting operations related to **Mombasa, Mombasa, KE** and international markets.
  • Develop, validate, and transfer analytical methods according to ICH guidelines and regulatory requirements.
  • Analyze and interpret test results, compare them against established specifications, and prepare detailed reports on findings.
  • Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results, identify root causes, and recommend corrective and preventive actions (CAPAs).
  • Maintain and calibrate laboratory equipment, ensuring its optimal performance and compliance with regulatory standards.
  • Ensure adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant quality systems and regulatory guidelines.
  • Review and approve analytical data, method validation reports, and other quality-related documentation.
  • Collaborate with R&D, manufacturing, and regulatory affairs departments to support product development and lifecycle management.
  • Train and mentor junior quality control analysts, providing guidance on analytical techniques and laboratory procedures.
  • Contribute to the continuous improvement of quality control processes and laboratory operations.
Qualifications:
  • Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related life science discipline.
  • Minimum of 6 years of hands-on experience in pharmaceutical quality control or analytical development.
  • Proficiency in operating and maintaining analytical instrumentation commonly used in pharmaceutical QC (e.g., HPLC, GC, dissolution testers).
  • Solid understanding of ICH guidelines, GMP, and other relevant pharmaceutical regulatory requirements.
  • Experience with method development and validation is essential.
  • Strong analytical and problem-solving skills with meticulous attention to detail.
  • Excellent written and verbal communication skills, with the ability to clearly document scientific data and findings.
  • Proven ability to work independently and manage time effectively in a remote laboratory support role.
  • Experience with LIMS (Laboratory Information Management System) is a plus.
This remote position offers a significant opportunity to advance your career in pharmaceutical quality assurance and contribute to the development of life-saving medications. If you are a skilled analyst with a passion for quality and regulatory compliance, we encourage you to apply.
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Remote Pharmaceutical Quality Control Scientist

80100 Nairobi, Nairobi KES180000 Annually WhatJobs

Posted 19 days ago

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Job Description

full-time
Our client, a growing pharmaceutical company, is seeking a talented and experienced Pharmaceutical Quality Control Scientist to join their fully remote team. This position is essential for ensuring the quality, safety, and efficacy of our client's pharmaceutical products. The successful candidate will be responsible for performing analytical testing, reviewing data, and contributing to the development and validation of quality control methods. You will work closely with the manufacturing, R&D, and regulatory affairs departments to ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines. The role requires meticulous attention to detail, a strong understanding of analytical chemistry techniques, and experience with quality management systems. The ability to interpret complex scientific data and generate clear, concise reports is paramount.

Key Responsibilities:
  • Perform a wide range of analytical tests on raw materials, in-process samples, and finished pharmaceutical products using various techniques (e.g., HPLC, GC, UV-Vis, Karl Fischer titration).
  • Develop, optimize, and validate analytical methods according to ICH guidelines and pharmacopoeial standards.
  • Review and interpret analytical data, ensuring accuracy and compliance with specifications.
  • Investigate out-of-specification (OOS) results and deviations, identifying root causes and implementing corrective and preventive actions (CAPAs).
  • Maintain accurate and comprehensive laboratory records, including data logs, instrument calibration, and maintenance logs.
  • Prepare Certificates of Analysis (CoA) and technical reports for internal stakeholders and regulatory submissions.
  • Contribute to the maintenance and improvement of the Quality Management System (QMS).
  • Stay updated on the latest scientific advancements, regulatory requirements, and industry best practices in pharmaceutical quality control.
  • Participate in internal and external audits as required.
  • Collaborate effectively with cross-functional teams in a remote environment to address quality-related issues.
  • Ensure laboratory safety protocols are strictly followed.

Qualifications:
  • Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline.
  • Minimum of 4 years of experience in pharmaceutical quality control or analytical development.
  • Hands-on experience with analytical instrumentation such as HPLC, GC, FTIR, UV-Vis spectrophotometry.
  • Strong knowledge of GMP, ICH guidelines, and pharmacopoeial standards (USP, EP).
  • Proficiency in data analysis and statistical evaluation.
  • Excellent documentation and report-writing skills.
  • Ability to work independently, manage time effectively, and meet deadlines in a remote setting.
  • Strong problem-solving and critical thinking abilities.
  • Effective communication and collaboration skills.
  • Familiarity with LIMS (Laboratory Information Management System) is an advantage.
This is a vital role that offers the opportunity to make a significant impact on product quality and patient safety while enjoying the benefits of a fully remote work arrangement.
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Senior Quality Control Manager - Food Manufacturing

80100 Nairobi, Nairobi KES550000 Annually WhatJobs

Posted 2 days ago

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Job Description

full-time
Our client, a prominent player in the food manufacturing industry, is seeking a Senior Quality Control Manager to oversee their quality assurance and control functions. This is a fully remote position, empowering you to manage quality protocols and standards from anywhere. You will be instrumental in developing, implementing, and maintaining comprehensive quality management systems that comply with all relevant food safety regulations and international standards. Your core responsibilities will include establishing quality control procedures, conducting regular audits of production processes, and analyzing product quality data to identify areas for improvement. You will lead a team of quality assurance professionals, providing guidance and mentorship to ensure consistent adherence to quality benchmarks. This role involves collaborating closely with production, R&D, and supply chain teams to address quality issues and implement corrective and preventive actions (CAPA). You will be responsible for managing all aspects of product testing, from raw material inspection to finished product analysis. Experience with HACCP, ISO 22000, and other food safety certifications is paramount. The ideal candidate will possess strong leadership skills, exceptional analytical abilities, and a meticulous approach to quality assurance. You must be adept at interpreting regulatory requirements and translating them into actionable quality policies. This remote role requires excellent communication and interpersonal skills to effectively engage with internal teams and external auditors. You will be expected to contribute to continuous improvement initiatives and drive a culture of quality excellence throughout the organization. A deep understanding of food science and manufacturing processes is essential. This is a critical role for ensuring the safety, quality, and integrity of our client's food products, offering a challenging and rewarding remote career opportunity.
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Remote Senior Pharmaceutical Quality Control Analyst

70105 Bahati, Nairobi KES88000 Annually WhatJobs remove_red_eye View All

Posted 9 days ago

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Job Description

full-time
Our client, a leading pharmaceutical company, is seeking a highly skilled and motivated Senior Pharmaceutical Quality Control Analyst to join their fully remote laboratory services team. This is a unique opportunity to contribute to drug development and manufacturing quality assurance from a remote setting. You will be responsible for performing a wide range of analytical tests on raw materials, intermediates, and finished pharmaceutical products to ensure they meet stringent quality standards and regulatory requirements. This role requires deep knowledge of analytical chemistry, quality control principles, and the ability to work independently with precision and accuracy.

Responsibilities:
  • Perform analytical testing on pharmaceutical materials using various laboratory techniques (e.g., HPLC, GC, spectroscopy, dissolution testing).
  • Analyze test data, interpret results, and prepare comprehensive analytical reports.
  • Ensure all testing is conducted in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory guidelines.
  • Validate analytical methods and instruments as required.
  • Troubleshoot analytical instrumentation and resolve laboratory issues.
  • Maintain accurate laboratory records and documentation, including logbooks and data files.
  • Participate in the investigation of Out-of-Specification (OOS) results and deviations.
  • Contribute to the continuous improvement of quality control processes and procedures.
  • Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, as needed.
  • Stay current with scientific advancements and regulatory expectations in pharmaceutical quality control.
Qualifications:
  • Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline. A Master's degree is a plus.
  • Minimum of 4 years of experience in pharmaceutical quality control or analytical testing.
  • Strong expertise in analytical techniques such as HPLC, GC, UV-Vis spectroscopy, and dissolution testing.
  • Thorough understanding of GMP/GLP regulations and quality control principles in the pharmaceutical industry.
  • Excellent data analysis, interpretation, and report writing skills.
  • Proficiency with laboratory information management systems (LIMS) and relevant software.
  • Ability to work independently, manage time effectively, and maintain high levels of accuracy in a remote laboratory setting.
  • Strong problem-solving abilities and attention to detail.
  • Good written and verbal communication skills.
  • Familiarity with method validation and instrument qualification is highly desirable.
  • This is a fully remote position, supporting critical quality functions for operations that may involve Mlolongo, Machakos, KE , but offering full remote work flexibility.
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Senior Pharmaceutical Quality Control Analyst - Remote

80100 Nairobi, Nairobi KES120000 Annually WhatJobs

Posted 17 days ago

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Job Description

full-time
Our client, a leading pharmaceutical innovator, is seeking an experienced Senior Pharmaceutical Quality Control Analyst to join their expanding remote team. This critical role will involve ensuring the highest standards of quality and compliance for our pharmaceutical products through rigorous remote analysis and reporting. You will be responsible for developing, validating, and implementing analytical methods, interpreting complex data, and ensuring all activities adhere to strict regulatory guidelines (e.g., GMP, ICH). The position demands a deep understanding of pharmaceutical manufacturing processes, analytical techniques, and quality management systems. You will conduct stability studies, perform raw material and finished product testing, and contribute to deviation investigations and CAPA (Corrective and Preventive Actions) management. Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, will be a key aspect of your role, requiring excellent communication and interpersonal skills to effectively convey technical information and findings in a virtual setting. A strong commitment to scientific integrity and a meticulous approach to documentation are essential. The ideal candidate will possess advanced analytical skills, a proven ability to troubleshoot and solve complex problems, and a track record of successfully contributing to quality assurance initiatives. Experience with various analytical instrumentation (HPLC, GC, UV-Vis, IR, etc.) and data analysis software is required. This is a unique opportunity for a dedicated pharmaceutical professional to make a significant impact on product quality and patient safety while working in a flexible, remote environment. You will be empowered to drive quality initiatives and contribute to the continuous improvement of our pharmaceutical portfolio. The role requires self-motivation, excellent time management, and the ability to thrive in an independent work setting, with regular virtual interaction with colleagues and supervisors.

Responsibilities:
  • Develop, validate, and implement analytical test methods for pharmaceutical products.
  • Conduct raw material, in-process, and finished product testing.
  • Analyze and interpret complex analytical data, generating comprehensive reports.
  • Perform stability studies and monitor product shelf-life.
  • Investigate deviations and contribute to CAPA development and implementation.
  • Ensure compliance with GMP, ICH guidelines, and other relevant regulatory standards.
  • Collaborate with R&D, manufacturing, and regulatory teams.
  • Maintain detailed and accurate laboratory records and documentation.
  • Operate and maintain analytical instrumentation (HPLC, GC, KF, etc.).
  • Contribute to process improvements and quality initiatives.
Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, or a related life science field.
  • Minimum of 5 years of experience in pharmaceutical quality control or assurance.
  • Extensive knowledge of GMP and regulatory requirements.
  • Proficiency in analytical techniques and instrumentation.
  • Strong data analysis and interpretation skills.
  • Excellent written and verbal communication skills.
  • Ability to work independently and manage multiple projects remotely.
  • Experience with LIMS and electronic data management systems is a plus.
This advertiser has chosen not to accept applicants from your region.

Principal Pharmaceutical Quality Assurance Engineer

80100 Nairobi, Nairobi KES180000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client, a renowned global pharmaceutical company, is seeking a highly experienced Principal Pharmaceutical Quality Assurance Engineer to join their dedicated remote team. This critical role will ensure the highest standards of quality and compliance are met throughout the pharmaceutical product lifecycle, from development to manufacturing and distribution. You will be instrumental in upholding Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other regulatory requirements, ensuring the safety and efficacy of life-saving medications. This position demands a rigorous approach to quality, deep regulatory knowledge, and exceptional leadership skills in a remote work environment. Responsibilities:
  • Lead and manage all aspects of the Quality Assurance (QA) function for pharmaceutical products, ensuring compliance with global regulatory standards (FDA, EMA, etc.).
  • Develop, implement, and maintain the company's Quality Management System (QMS), including SOPs, batch records, and validation protocols.
  • Oversee the quality control of raw materials, in-process testing, and finished product release.
  • Conduct internal audits and host regulatory inspections, ensuring readiness and compliance.
  • Investigate deviations, non-conformances, and CAPA (Corrective and Preventive Actions), implementing effective solutions to prevent recurrence.
  • Review and approve manufacturing process validation, equipment qualification, and cleaning validation reports.
  • Manage change control processes and ensure all changes are properly assessed, documented, and implemented.
  • Provide QA oversight for product development, technology transfer, and commercial manufacturing activities.
  • Train and mentor QA team members and other personnel on quality systems and regulatory requirements.
  • Collaborate with cross-functional teams, including R&D, manufacturing, supply chain, and regulatory affairs, to ensure integrated quality approaches.
  • Stay current with evolving regulatory expectations and industry best practices in pharmaceutical quality assurance.
  • Contribute to strategic quality initiatives and continuous improvement programs.
Qualifications:
  • Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, Engineering, or a related scientific discipline.
  • Minimum of 10 years of progressive experience in pharmaceutical Quality Assurance and Quality Control.
  • Extensive knowledge of GMP, GLP, ICH guidelines, and regulatory submission requirements.
  • Proven experience in developing, implementing, and managing robust QMS.
  • Strong background in validation (process, equipment, cleaning) and batch record review.
  • Demonstrated experience in managing deviations, CAPAs, and change controls.
  • Excellent leadership, communication, and interpersonal skills, with the ability to influence and drive compliance.
  • Experience with sterile manufacturing and aseptic processing is highly advantageous.
  • Proficiency in quality risk management principles.
  • Ability to work autonomously, manage complex projects, and lead remote teams effectively.
  • Familiarity with pharmaceutical manufacturing processes and analytical testing methods.
This is an exceptional remote opportunity for a seasoned QA professional to make a profound impact on patient safety and product quality within a leading pharmaceutical organization. If you possess a meticulous attention to detail and a commitment to excellence, we invite you to apply.
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Remote Quality Control Supervisor - Sanitation Standards

80100 Nairobi, Nairobi KES80000 Annually WhatJobs

Posted 4 days ago

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Job Description

full-time
Our client is seeking a diligent and detail-oriented Remote Quality Control Supervisor to ensure the highest standards of sanitation and cleanliness are maintained across their operational sites. This is a fully remote position that requires a strong understanding of hygiene protocols, quality assurance methodologies, and team supervision. You will be responsible for developing and implementing remote inspection procedures, conducting virtual site assessments, and analyzing reports to identify areas needing improvement. Your role will involve training and guiding a distributed team of cleaning staff on adherence to established standards, ensuring compliance with health and safety regulations. The ideal candidate will possess extensive experience in cleaning and sanitation management, with a proven ability to implement and enforce quality control measures. Excellent observational skills, a keen eye for detail, and strong communication abilities are essential for providing constructive feedback and support remotely. You will also be tasked with maintaining accurate records, documenting findings, and preparing regular reports on quality performance. This position demands a proactive approach to problem-solving and the ability to maintain high standards in a remote work environment. We are looking for an individual who is passionate about maintaining pristine environments and ensuring operational excellence. The ability to manage a dispersed team effectively, provide clear guidance, and drive continuous improvement is crucial. The physical location context for the wide-ranging operational needs this role supports is Mombasa, Mombasa, KE .
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Senior Quality Control Manager - Pharmaceutical

80100 Nairobi, Nairobi KES5300000 Annually WhatJobs

Posted 19 days ago

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Job Description

full-time
Our client is seeking a highly experienced and detail-oriented Senior Quality Control Manager to lead their pharmaceutical quality assurance efforts. This is a critical, fully remote role responsible for upholding the highest standards of quality and compliance in pharmaceutical product development and manufacturing. The ideal candidate will possess a comprehensive understanding of GMP (Good Manufacturing Practices), regulatory affairs, and quality management systems within the pharmaceutical industry. You will be tasked with developing, implementing, and maintaining robust quality control procedures, overseeing testing processes, and ensuring that all products meet stringent safety and efficacy standards before release. This position requires exceptional leadership skills, analytical acumen, and the ability to manage and mentor a remote team of quality professionals.

Responsibilities:
  • Develop, implement, and manage the company's quality control systems and procedures for pharmaceutical products.
  • Oversee all aspects of product testing, including raw materials, in-process samples, and finished goods.
  • Ensure compliance with national and international regulatory standards, including GMP, FDA, and ICH guidelines.
  • Manage and mentor a remote team of QC analysts and technicians, providing technical guidance and training.
  • Review and approve quality control data, batch records, and release documentation.
  • Investigate deviations, out-of-specification results, and customer complaints, implementing corrective and preventive actions (CAPAs).
  • Develop and validate analytical methods to ensure accuracy and reliability of test results.
  • Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality throughout the lifecycle.
  • Conduct internal audits and support external regulatory inspections.
  • Stay current with evolving regulatory requirements and industry best practices in pharmaceutical quality control.

Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 7 years of experience in pharmaceutical quality control or quality assurance, with at least 3 years in a management role.
  • Extensive knowledge of GMP, quality systems, and regulatory compliance in the pharmaceutical industry.
  • Proven experience in analytical method development and validation.
  • Strong understanding of pharmaceutical manufacturing processes.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Exceptional leadership, communication, and interpersonal skills.
  • Ability to effectively manage and motivate a remote team.
  • Proficiency in quality control laboratory instrumentation and software.
  • This is a fully remote position, offering unparalleled flexibility. The nominal administrative base for this role is Mombasa, Mombasa, KE , but the work is performed entirely remotely.
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Lead Pharmaceutical Quality Assurance Specialist

80200 Nairobi, Nairobi KES550000 Annually WhatJobs

Posted 2 days ago

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Job Description

full-time
Our client, a leading pharmaceutical innovator, is seeking an experienced and meticulous Lead Pharmaceutical Quality Assurance Specialist to join their globally distributed team. This position is 100% remote, allowing you to contribute to critical quality initiatives from your home office. You will be responsible for ensuring compliance with current Good Manufacturing Practices (cGMP) and other relevant regulatory standards across all phases of drug development and manufacturing. This includes developing, implementing, and maintaining quality management systems, overseeing batch record reviews, managing deviations and change controls, and conducting internal audits. You will lead and mentor a team of QA professionals, fostering a culture of quality and continuous improvement. The role involves close collaboration with regulatory affairs, R&D, and manufacturing departments to ensure product integrity and patient safety. A strong understanding of pharmaceutical manufacturing processes, analytical testing, and validation principles is essential. You will be involved in preparing for regulatory inspections by agencies such as the FDA and EMA. The ideal candidate will possess exceptional attention to detail, strong analytical and problem-solving abilities, and excellent communication skills, both written and verbal, to effectively interact with cross-functional teams and stakeholders. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field is required. A minimum of 8 years of progressive experience in pharmaceutical quality assurance is necessary. Experience with electronic quality management systems (eQMS) is a plus. This remote role requires a self-starter with the ability to manage time effectively and meet stringent deadlines. You will play a pivotal role in upholding the highest standards of quality in our client's pharmaceutical products. This opportunity, located virtually for **Malindi, Kilifi, KE**, offers a chance to make a significant impact on global health.
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Senior Pharmaceutical Quality Assurance Specialist

80100 Nairobi, Nairobi KES280000 Monthly WhatJobs remove_red_eye View All

Posted 16 days ago

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Job Description

full-time
Our client, a leading name in the pharmaceutical industry, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their esteemed team on a fully remote basis. This critical role ensures that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be responsible for developing, implementing, and maintaining quality management systems, conducting audits, and ensuring compliance with cGMP, ICH guidelines, and other relevant regulations. As a remote professional, you will collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, utilizing advanced digital communication tools to maintain oversight and drive quality initiatives. The ideal candidate possesses a deep understanding of pharmaceutical quality systems and a meticulous attention to detail.

Responsibilities:
  • Develop, implement, and maintain the company's Quality Management System (QMS).
  • Conduct internal and external audits of suppliers, contract manufacturers, and internal processes.
  • Review and approve batch records, validation protocols, and other critical quality documentation.
  • Investigate deviations, out-of-specification (OOS) results, and customer complaints, implementing CAPA (Corrective and Preventive Actions).
  • Ensure compliance with cGMP, FDA, EMA, and other relevant regulatory guidelines.
  • Participate in regulatory inspections and respond to regulatory inquiries.
  • Develop and deliver quality training programs to relevant personnel.
  • Monitor key quality metrics and provide regular reports to management.
  • Stay updated on evolving regulatory requirements and industry best practices.
  • Contribute to the continuous improvement of quality processes and systems.
  • Oversee change control processes and risk assessments.
  • Manage documentation control processes to ensure accuracy and accessibility.

Qualifications:
  • Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
  • Minimum of 5 years of experience in Pharmaceutical Quality Assurance or Quality Control.
  • In-depth knowledge of cGMP, ICH guidelines, and other relevant regulatory standards.
  • Proven experience in conducting audits and managing QMS.
  • Strong understanding of pharmaceutical manufacturing processes.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Proficiency in documentation review and investigation processes.
  • Exceptional communication and interpersonal skills, with the ability to collaborate effectively in a remote team environment.
  • Experience with electronic QMS is a plus.
  • Must be legally authorized to work in Kenya.

This is an exceptional opportunity for a seasoned QA professional to contribute significantly to patient safety and product quality in a fully remote capacity, based in **Mombasa, Mombasa, KE**. Join a progressive organization that values expertise, dedication, and the well-being of its remote workforce.
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