6,524 Senior Pharmaceutical Quality Assurance Specialist Remote Compliance Officer jobs in Kenya
Senior Pharmaceutical Quality Assurance Specialist - Remote Compliance Officer
Posted 22 days ago
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Job Description
Our client is seeking a highly experienced and meticulous Senior Pharmaceutical Quality Assurance Specialist to join their fully remote global team. This role is crucial for ensuring the integrity, safety, and efficacy of pharmaceutical products by upholding stringent quality standards and regulatory compliance. As a remote specialist, you will be responsible for developing, implementing, and maintaining robust quality management systems, conducting comprehensive audits, and driving continuous improvement initiatives across all stages of drug development and manufacturing. Your expertise will be vital in navigating the complex regulatory landscape and ensuring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant guidelines.
Key responsibilities include:
Key responsibilities include:
- Developing, implementing, and overseeing pharmaceutical quality assurance programs and policies.
- Conducting internal and external audits of manufacturing facilities, laboratories, and clinical trial sites to ensure compliance with regulatory standards (e.g., FDA, EMA, WHO).
- Reviewing and approving batch records, validation protocols, and other critical quality documentation.
- Investigating deviations, out-of-specification (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPAs).
- Ensuring that all pharmaceutical products meet predefined quality specifications and regulatory requirements before release.
- Collaborating closely with R&D, manufacturing, regulatory affairs, and clinical teams to ensure quality is integrated throughout the product lifecycle.
- Developing and delivering quality assurance training programs for relevant personnel.
- Managing and maintaining the company's Quality Management System (QMS), including document control, change control, and risk management processes.
- Staying updated on current pharmaceutical regulations, industry trends, and best practices in quality assurance.
- Preparing for and hosting regulatory inspections and customer audits.
- A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Ph.D. is a plus.
- A minimum of 7-10 years of progressive experience in pharmaceutical quality assurance and/or quality control.
- In-depth knowledge of GMP, GCP, ICH guidelines, and other relevant global regulatory requirements.
- Proven experience in conducting successful regulatory audits and hosting inspections.
- Strong analytical skills with the ability to interpret complex data and resolve quality issues effectively.
- Excellent project management and organizational skills, with the ability to manage multiple tasks and projects concurrently in a remote setting.
- Outstanding written and verbal communication skills, with the ability to articulate complex quality and regulatory issues clearly.
- Proficiency in quality management software and tools.
- A proactive approach to problem-solving and a commitment to maintaining the highest quality standards.
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Lead Pharmaceutical QA/QC Specialist (Remote)
Posted 21 days ago
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Job Description
Our client, a dynamic pharmaceutical company, is seeking a dedicated and experienced Lead Pharmaceutical QA/QC Specialist to manage and enhance quality assurance and quality control processes from a fully remote position. This critical role involves ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be responsible for developing, implementing, and maintaining robust quality systems, overseeing testing procedures, and ensuring compliance with cGMP and other relevant guidelines. This position is perfect for a meticulous professional who excels in a remote work environment and can lead quality initiatives effectively.
Responsibilities:
Qualifications:
This is a significant opportunity to lead quality initiatives and ensure the highest standards in pharmaceutical manufacturing, all within a remote work structure. You will play a crucial role in safeguarding product integrity and patient safety, contributing to operations relevant to **Nyeri, Nyeri, KE**, and the broader pharmaceutical landscape, as a valued member of our remote-first organization.
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Assurance (QA) and Quality Control (QC) systems.
- Oversee the execution of analytical testing for raw materials, in-process samples, and finished products.
- Ensure compliance with cGMP, ICH guidelines, and other relevant regulatory standards.
- Write, review, and approve Standard Operating Procedures (SOPs), batch records, and validation protocols.
- Manage deviations, Out-of-Specification (OOS) results, and CAPA investigations.
- Conduct internal audits and support external regulatory inspections.
- Train and mentor QA/QC personnel.
- Analyze quality data to identify trends and implement continuous improvement initiatives.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality and compliance.
- Stay current with evolving regulatory requirements and industry best practices in pharmaceutical quality management.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. M.Sc. or Ph.D. is a plus.
- Minimum of 7 years of progressive experience in pharmaceutical Quality Assurance and/or Quality Control.
- In-depth knowledge of cGMP regulations, ICH guidelines, and pharmaceutical manufacturing processes.
- Proven experience in managing analytical testing, method validation, and stability studies.
- Strong understanding of quality management systems, including deviation management, CAPA, and change control.
- Excellent documentation, analytical, and problem-solving skills.
- Strong leadership and team management capabilities.
- Exceptional communication and interpersonal skills, with the ability to collaborate effectively in a remote setting.
- Experience with electronic quality management systems (eQMS) is beneficial.
- Detail-oriented with a strong commitment to quality and compliance.
This is a significant opportunity to lead quality initiatives and ensure the highest standards in pharmaceutical manufacturing, all within a remote work structure. You will play a crucial role in safeguarding product integrity and patient safety, contributing to operations relevant to **Nyeri, Nyeri, KE**, and the broader pharmaceutical landscape, as a valued member of our remote-first organization.
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Pharmaceutical Quality Control Specialist
Posted 13 days ago
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Job Description
Our client is seeking a highly meticulous and diligent Pharmaceutical Quality Control Specialist to uphold the highest standards of product integrity within their operations, operating in a fully remote capacity. This role is vital in ensuring that all pharmaceutical products meet rigorous quality specifications and regulatory requirements. The ideal candidate will possess a strong understanding of pharmaceutical manufacturing processes, quality assurance principles, and relevant regulatory guidelines (e.g., GMP, ICH). You will be responsible for reviewing and analyzing batch records, conducting laboratory data analysis, and performing validation testing. This position requires exceptional attention to detail, strong analytical skills, and the ability to interpret scientific data accurately in a remote environment. Key responsibilities include identifying deviations from quality standards, participating in investigations of quality issues, and contributing to the continuous improvement of quality systems. You will collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality throughout its lifecycle. We are looking for a candidate with a Bachelor's degree in a relevant scientific field (e.g., Pharmacy, Chemistry, Biotechnology) and a proven track record in pharmaceutical quality control. If you are a proactive professional committed to ensuring patient safety and product efficacy, and seeking a rewarding remote career, we encourage you to apply. Your home office will serve as your operational base, requiring a stable internet connection for accessing quality management systems and collaborating with colleagues. This role offers a competitive salary and the opportunity to contribute to the development and manufacturing of essential medicines. Your dedication to quality assurance will be paramount in safeguarding public health and maintaining our client's reputation for excellence.
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Principal Pharmaceutical Quality Assurance Engineer
Posted 7 days ago
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Job Description
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.
- 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.
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Remote Pharmaceutical Quality Control Specialist
Posted 20 days ago
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Job Description
Our client, a leading entity in the pharmaceutical sector, is actively searching for a dedicated and detail-oriented Pharmaceutical Quality Control Specialist to join their operations. This position is exclusively remote, allowing you to contribute your expertise from the comfort of your home office. The successful candidate will play a crucial role in ensuring the quality, safety, and efficacy of pharmaceutical products by adhering to stringent regulatory standards. Your responsibilities will encompass reviewing and analyzing quality data, investigating deviations and out-of-specification results, preparing batch records for release, and participating in internal and external audits. You will also be instrumental in the development and implementation of quality control procedures and protocols. Strong analytical skills, a thorough understanding of Good Manufacturing Practices (GMP), and familiarity with pharmaceutical quality systems are paramount. The ideal candidate will possess excellent written and verbal communication skills, enabling clear documentation and effective collaboration with cross-functional teams. Proficiency in using quality control instrumentation and laboratory information management systems (LIMS) is highly desirable. A bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline is required. Advanced degrees or relevant certifications will be an added advantage. Prior experience in pharmaceutical quality assurance or quality control is essential. This role demands a meticulous approach, a commitment to compliance, and the ability to work independently with minimal supervision. If you are passionate about ensuring product integrity and eager to advance your career in a remote pharmaceutical setting, this opportunity is ideal for you. This position is intrinsically linked to operations in **Machakos, Machakos, KE**, but offers full remote work flexibility.
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Senior Pharmaceutical Quality Control Specialist
Posted 15 days ago
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Job Description
Our client is seeking a highly qualified Senior Pharmaceutical Quality Control Specialist to ensure the highest standards of pharmaceutical product quality. This is a fully remote position, allowing you to contribute your expertise from any location. You will be responsible for designing and implementing robust quality control protocols, analyzing raw materials and finished products, and ensuring compliance with regulatory requirements. Your duties will include performing analytical testing, validating testing methods, documenting quality control procedures, and investigating deviations from quality standards. The ideal candidate will have a strong background in pharmaceutical sciences, with extensive experience in quality assurance and quality control within the pharmaceutical industry. Proficiency in analytical techniques such as HPLC, GC, and spectroscopy is essential. You should possess exceptional attention to detail, strong problem-solving skills, and a thorough understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Experience with regulatory submissions and audits is highly desirable. This role offers an exciting opportunity to make a significant impact on patient safety and product efficacy, all within a flexible remote work arrangement. You will be a key player in upholding our client's commitment to quality and regulatory excellence. We are looking for a dedicated professional who can maintain meticulous records and drive continuous improvement in quality processes. This is an ideal role for a seasoned specialist looking for a senior-level remote opportunity, contributing to the pharmaceutical sector from the heart of Kakamega, Kakamega, KE .
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Pharmaceutical Quality Assurance Specialist
Posted 22 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a meticulous and experienced Pharmaceutical Quality Assurance Specialist to join their team based in **Nyeri, Nyeri, KE**. This hybrid role requires a professional who can balance on-site responsibilities with remote work flexibility. You will be instrumental in ensuring that all pharmaceutical products meet rigorous quality standards and comply with regulatory requirements. Your primary responsibilities will include developing, implementing, and maintaining quality assurance systems, conducting internal audits, reviewing batch records, and investigating deviations and non-conformances. You will work closely with manufacturing, R&D, and regulatory affairs departments to ensure product integrity throughout its lifecycle. The ideal candidate will possess a strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant international regulatory guidelines. Excellent analytical, problem-solving, and documentation skills are essential. You must be proficient in quality management software and possess a keen eye for detail. This role demands a high level of integrity and a commitment to upholding the highest ethical standards in pharmaceutical quality. You will be involved in risk assessments, process validation, and continuous improvement initiatives. The ability to interpret complex technical data and translate it into actionable quality improvements is crucial. You will also play a role in training personnel on quality procedures and ensuring adherence to company policies. This position offers a fantastic opportunity to contribute to the development and manufacturing of life-saving medications within a respected organization. A strong scientific background, coupled with practical experience in a QA/QC environment, is highly desirable. The hybrid nature of this role allows for focused work at home, interspersed with essential on-site activities critical for quality oversight.
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Lead Pharmaceutical Quality Assurance Specialist
Posted 20 days ago
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Job Description
Our client is seeking a highly experienced and detail-oriented Lead Pharmaceutical Quality Assurance Specialist to ensure the highest standards of compliance and product integrity within their fully remote operations. This critical role involves developing, implementing, and maintaining robust quality management systems in accordance with global regulatory standards. The ideal candidate will possess deep expertise in pharmaceutical manufacturing processes, regulatory affairs, and quality control methodologies. You will lead quality initiatives, conduct audits, and drive continuous improvement, all from a remote work setting. This is a remote-first position, offering a significant opportunity for impact from anywhere in Kenya.
Responsibilities:
Responsibilities:
- Develop, implement, and manage comprehensive Quality Assurance (QA) programs for pharmaceutical products and processes.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulatory guidelines (e.g., FDA, EMA).
- Conduct internal and external audits of manufacturing sites, suppliers, and contract manufacturers.
- Review and approve batch records, validation protocols, and other critical quality documentation.
- Investigate deviations, out-of-specifications (OOS) results, and customer complaints, implementing corrective and preventive actions (CAPA).
- Develop and maintain the company's Quality Management System (QMS), including SOPs, work instructions, and quality agreements.
- Provide training to personnel on QA principles, GMP, and regulatory requirements.
- Collaborate with R&D, manufacturing, and regulatory affairs departments to ensure product quality throughout the lifecycle.
- Manage the release of finished pharmaceutical products.
- Stay current with evolving regulatory landscapes and industry best practices.
- Lead quality improvement initiatives and contribute to the continuous enhancement of quality systems.
- Prepare for and host regulatory inspections.
- Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related scientific field.
- A minimum of 8 years of experience in Pharmaceutical Quality Assurance and Quality Control, with a strong focus on GMP compliance.
- In-depth knowledge of pharmaceutical manufacturing processes, analytical testing, and stability studies.
- Proven experience in conducting audits and managing CAPA systems.
- Familiarity with global regulatory requirements and submission processes.
- Excellent understanding of quality risk management principles.
- Strong analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to present complex information clearly and concisely.
- Demonstrated leadership capabilities and the ability to manage projects and teams remotely.
- Proficiency in using quality management software and standard office applications.
- Relevant professional certifications (e.g., ASQ CQA) are a plus.
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Lead Quality Assurance Engineer - Manufacturing
Posted 12 days ago
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Job Description
Our client is seeking a results-driven Lead Quality Assurance Engineer to oversee manufacturing quality processes in a fully remote capacity. This role is pivotal in ensuring that all manufactured products meet stringent quality standards and regulatory requirements. You will be responsible for developing, implementing, and managing comprehensive quality assurance programs and procedures throughout the production lifecycle. This includes establishing quality metrics, conducting root cause analyses for defects, and implementing corrective and preventive actions (CAPA). You will lead a remote QA team, providing guidance, training, and performance management. Experience with quality management systems (QMS) such as ISO 9001, Lean Manufacturing principles, and Six Sigma methodologies is essential. You will be instrumental in developing and maintaining inspection and testing protocols, analyzing production data to identify trends and areas for improvement, and collaborating with production and engineering teams to resolve quality issues. A strong understanding of statistical process control (SPC) and quality control tools is required. The ideal candidate will possess excellent analytical, problem-solving, and communication skills, with the ability to work independently and manage complex quality assurance projects in a remote setting. This is a fantastic opportunity to drive excellence in manufacturing quality and contribute to product integrity for our client's operations, even while working remotely from **Nakuru, Nakuru, KE**. A Bachelor's degree in Engineering (Mechanical, Industrial, or related field) or a related discipline is required, along with a minimum of 7 years of experience in quality assurance within a manufacturing environment, with at least 3 years in a leadership or supervisory role. Relevant certifications (e.g., ASQ Certified Quality Engineer) are a plus.
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8
Remote Sanitation Supervisor - Quality Assurance
Posted 12 days ago
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Job Description
Our client is seeking a meticulous and experienced Remote Sanitation Supervisor to oversee and ensure the highest standards of cleanliness and sanitation across various operational sites, managed entirely from a remote location. In this role, you will be pivotal in developing, implementing, and monitoring comprehensive sanitation protocols and quality assurance programs. Your primary responsibility will be to conduct virtual audits, analyze sanitation reports, and provide expert guidance to on-site teams to maintain a safe and hygienic environment. This position demands exceptional organizational skills, a keen eye for detail, and the ability to communicate effectively with diverse teams across different locations. You will leverage technology to perform site assessments, review maintenance logs, and ensure compliance with health and safety regulations. The ideal candidate will have a strong background in industrial or commercial sanitation, a deep understanding of best practices, and the ability to troubleshoot and resolve sanitation-related issues remotely. You will be responsible for training materials development and delivery for on-site staff, ensuring they are up-to-date with the latest sanitation procedures. Proactive identification of potential risks and development of mitigation strategies will be a key part of your role. This is a remote-first position, requiring you to manage your schedule effectively and maintain consistent communication with stakeholders. Experience with HACCP or similar food safety standards is highly desirable.
Responsibilities:
Responsibilities:
- Develop, implement, and refine sanitation policies and procedures.
- Conduct remote inspections and quality assurance checks of facilities.
- Analyze sanitation data and generate reports on compliance and areas for improvement.
- Provide virtual guidance and support to on-site cleaning and maintenance staff.
- Ensure adherence to all relevant health, safety, and environmental regulations.
- Develop and deliver training programs for sanitation personnel.
- Investigate and resolve sanitation-related issues promptly.
- Maintain detailed records of inspections, audits, and corrective actions.
- Monitor inventory of cleaning supplies and equipment, advising on procurement needs.
- Stay updated on industry best practices and emerging sanitation technologies.
- Proven experience in sanitation management, quality control, or a related field.
- Strong understanding of sanitation principles, regulations, and best practices.
- Excellent remote communication, analytical, and problem-solving skills.
- Proficiency in using digital tools for reporting, data analysis, and virtual collaboration.
- Ability to train and guide staff effectively from a distance.
- Experience in food service, healthcare, or manufacturing sanitation is a plus.
- Relevant certifications in sanitation or hygiene are advantageous.
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