924 Senior Pharmaceutical Quality Control Analyst jobs in Nairobi
Senior Pharmaceutical Quality Control Analyst
Posted 19 days ago
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Job Description
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:
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.
- 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.
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Remote Senior Pharmaceutical Quality Control Analyst
Posted 9 days ago
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Job Description
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:
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.
- 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
Posted 17 days ago
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Job Description
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:
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.
- 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.
2
Senior Quality Control Specialist - Remote
Posted 19 days ago
Job Viewed
Job Description
Our client, a premier provider of specialized cleaning and sanitation services for the hospitality and healthcare sectors, is seeking an experienced Senior Quality Control Specialist to join their expanding, fully remote operations. This role is critical in ensuring the highest standards of cleanliness and hygiene across all client sites, managed remotely through sophisticated digital platforms. The ideal candidate will have a meticulous eye for detail, a strong understanding of sanitation protocols, and the ability to implement and monitor quality assurance programs effectively. Responsibilities include developing and refining quality control checklists and audit procedures, conducting remote audits of cleaning operations using digital reporting tools and video verification, and analyzing performance data to identify areas for improvement. You will train and mentor cleaning staff on best practices and adherence to quality standards via virtual platforms. Developing and delivering training materials on sanitation techniques, safety protocols, and the use of specialized equipment will be a core function. You will be responsible for investigating client complaints or quality issues, identifying root causes, and implementing corrective actions. Collaboration with operations managers to ensure consistent service delivery and client satisfaction is key. Staying abreast of industry best practices, regulatory requirements, and emerging sanitation technologies is essential. The ability to work independently, manage time effectively, and communicate clearly and professionally with both on-site teams and remote management is paramount. Our client is committed to providing a safe and healthy environment for all stakeholders, and this role plays a crucial part in upholding that commitment. This is a unique opportunity to leverage your expertise in quality control within a leading sanitation company, contributing to operational excellence from a remote setting. A background in Environmental Health, Public Health, or a related field, coupled with significant experience in quality assurance within the cleaning or facilities management industry, is required.
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3
Senior Quality Control Specialist, Sanitation (Remote)
Posted 9 days ago
Job Viewed
Job Description
Our client, a leader in the cleaning and sanitation services industry, is looking for a meticulous and experienced Senior Quality Control Specialist to oversee their remote operations. This is an excellent opportunity to contribute to maintaining the highest standards of cleanliness and hygiene from the convenience of your home office. You will be responsible for developing, implementing, and monitoring quality control procedures and standards across various service delivery points. Your role will involve conducting audits, analyzing performance data, identifying areas for improvement, and recommending corrective actions. You will also train and guide on-site teams on best practices in sanitation and hygiene, ensuring compliance with health regulations and company policies.
Key Responsibilities:
Key Responsibilities:
- Develop and refine quality control protocols for cleaning and sanitation services.
- Conduct remote audits and inspections of service delivery sites, assessing adherence to standards.
- Analyze performance metrics, identify trends, and prepare detailed quality reports.
- Investigate customer complaints and operational issues related to sanitation and hygiene.
- Implement corrective and preventive actions to address quality deviations.
- Train and mentor field staff on updated sanitation procedures, safety protocols, and quality expectations.
- Ensure compliance with all relevant health, safety, and environmental regulations.
- Collaborate with operational managers to drive continuous improvement in service quality.
- Stay informed about the latest advancements in cleaning technologies and hygiene practices.
- Maintain accurate records of inspections, audits, and quality improvement initiatives.
This advertiser has chosen not to accept applicants from your region.
4
Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client, a dynamic and growing pharmaceutical company, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote team. This role is essential for ensuring compliance with global regulatory standards and for successfully navigating the complex landscape of drug approvals and lifecycle management. The ideal candidate will possess a strong understanding of pharmaceutical regulations, a meticulous attention to detail, and excellent communication skills to liaise with health authorities and internal stakeholders. This remote position requires a self-motivated individual who can manage multiple regulatory submissions and projects concurrently while maintaining the highest standards of quality and integrity.
Responsibilities:
Required Qualifications:
This is a rewarding remote role for a dedicated regulatory professional looking to make a significant contribution to bringing vital medicines to patients.
Responsibilities:
- Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA, ANDA) to health authorities worldwide.
- Interpret and advise on regulatory requirements and guidelines for drug development, manufacturing, and marketing.
- Develop regulatory strategies to support product development and commercialization plans.
- Liaise with regulatory agencies (e.g., FDA, EMA, local authorities) on submissions, inquiries, and meetings.
- Manage post-approval regulatory activities, including variations, annual reports, and renewals.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Review promotional materials and labeling for regulatory compliance.
- Collaborate with R&D, Clinical, Quality Assurance, and Commercial teams to ensure regulatory requirements are met throughout the product lifecycle.
- Monitor regulatory intelligence and update company policies and procedures accordingly.
- Provide training to internal teams on regulatory requirements and best practices.
- Assess the regulatory impact of proposed product changes or new developments.
- Maintain accurate and organized regulatory records and databases.
Required Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- A minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulations (e.g., ICH guidelines, US FDA, EMA).
- Proven experience in preparing and submitting various types of regulatory dossiers.
- Excellent understanding of drug development processes and product lifecycle management.
- Strong analytical and problem-solving skills with meticulous attention to detail.
- Exceptional written and verbal communication skills, with the ability to draft clear and concise regulatory documents.
- Ability to work independently, manage priorities effectively, and meet strict deadlines in a remote setting.
- Strong interpersonal skills and the ability to collaborate effectively with diverse teams.
- Experience with regulatory information management systems is a plus.
- Pharmaceutical industry experience is mandatory.
This is a rewarding remote role for a dedicated regulatory professional looking to make a significant contribution to bringing vital medicines to patients.
This advertiser has chosen not to accept applicants from your region.
5
Lead Pharmaceutical Quality Assurance Specialist
Posted 2 days ago
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Job Description
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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6
Senior Pharmaceutical Quality Assurance Specialist
Posted 16 days ago
Job Viewed
Job Description
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:
Qualifications:
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.
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.
This advertiser has chosen not to accept applicants from your region.
7
Remote Pharmaceutical Quality Assurance Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client, a reputable pharmaceutical company, is seeking a detail-oriented and experienced Remote Pharmaceutical Quality Assurance Specialist. In this fully remote role, you will be responsible for ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout the development and manufacturing lifecycle. Your duties will include reviewing documentation, performing audits, investigating deviations, and implementing corrective and preventive actions (CAPA). This position requires a thorough understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory guidelines. Success hinges on your ability to meticulously manage quality processes, collaborate effectively with cross-functional teams remotely, and uphold the highest standards of pharmaceutical quality, without being based at our **Mombasa, Mombasa, KE** facility.
Responsibilities:
Responsibilities:
- Develop, implement, and maintain quality management systems and procedures.
- Review and approve batch records, validation protocols, and other quality-related documentation.
- Conduct internal audits and participate in external audits of suppliers and partners.
- Investigate deviations, out-of-specifications (OOS) results, and customer complaints.
- Develop and implement corrective and preventive actions (CAPA) to address quality issues.
- Ensure compliance with relevant regulatory requirements (e.g., FDA, EMA, local health authorities).
- Train personnel on quality assurance policies and procedures.
- Monitor and analyze quality metrics and trends, reporting findings to management.
- Participate in process validation and qualification activities.
- Manage the change control process effectively.
- Stay updated on regulatory changes and industry best practices in pharmaceutical quality assurance.
- Contribute to the continuous improvement of quality systems.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 3-5 years of experience in pharmaceutical quality assurance or quality control.
- In-depth knowledge of GMP, GLP, and other relevant quality standards.
- Familiarity with regulatory submission processes and requirements.
- Strong understanding of pharmaceutical manufacturing processes.
- Excellent analytical, problem-solving, and investigative skills.
- Exceptional attention to detail and accuracy.
- Strong written and verbal communication skills, adapted for remote collaboration.
- Ability to work independently, prioritize tasks, and manage time effectively in a remote environment.
- Proficiency in quality management software and MS Office Suite.
This advertiser has chosen not to accept applicants from your region.
8
Senior Remote Pharmaceutical Regulatory Affairs Specialist
Posted 2 days ago
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Job Description
Our client is seeking a highly experienced Senior Remote Pharmaceutical Regulatory Affairs Specialist to lead and manage regulatory submissions and compliance efforts. This fully remote position allows you to contribute significantly to bringing life-saving medications to market from the convenience of your home office. You will be responsible for interpreting and applying global regulatory guidelines, preparing comprehensive regulatory dossiers, and ensuring timely submissions to health authorities worldwide. Key duties include developing regulatory strategies, liaising with regulatory agencies, conducting regulatory intelligence activities, and advising internal teams on regulatory requirements and potential challenges. The ideal candidate will possess a strong background in pharmaceutical sciences or a related field, with extensive experience in regulatory affairs for both pre-market approval and post-market activities. A deep understanding of regulatory submission processes (e.g., CTD, IND, NDA) and familiarity with international regulatory landscapes (e.g., FDA, EMA) are essential. Excellent written and verbal communication skills are critical for effectively preparing submission documents and interacting with regulatory bodies. You must demonstrate strong analytical and problem-solving abilities, meticulous attention to detail, and the capacity to manage complex projects under tight deadlines. This role requires a proactive and strategic thinker with the ability to anticipate regulatory changes and provide sound advice. Proficiency in regulatory information management systems is a plus. Join our client’s esteemed regulatory team and play a vital role in ensuring the successful and compliant market access of innovative pharmaceutical products. Your expertise will be invaluable in navigating the complex regulatory environment.
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