6,785 Principal Pharmaceutical Quality Assurance Specialist Remote jobs in Kenya
Principal Pharmaceutical Quality Assurance Specialist (Remote)
Posted 21 days ago
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Job Description
Our client, a globally recognized leader in the Pharmaceutical industry, is seeking an experienced Principal Pharmaceutical Quality Assurance Specialist to join their esteemed team. This is a critical, fully remote position that plays a pivotal role in ensuring the highest standards of quality and compliance across all pharmaceutical operations. The ideal candidate will possess an in-depth understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory requirements across key markets. You will be responsible for developing, implementing, and maintaining robust quality management systems, conducting internal and external audits, and driving continuous improvement initiatives. This role requires exceptional attention to detail, strong analytical skills, and the ability to effectively manage complex quality assurance processes from a remote setting.
Responsibilities:
Qualifications:
Responsibilities:
- Develop, implement, and manage comprehensive quality assurance programs and systems in compliance with regulatory standards (e.g., FDA, EMA).
- Lead and conduct internal audits of manufacturing sites, laboratories, and distribution centers to ensure adherence to GMP, GLP, and other relevant regulations.
- Oversee the investigation of deviations, CAPA (Corrective and Preventive Actions) implementation, and change control processes.
- Review and approve critical quality documents, including batch records, validation protocols, and SOPs.
- Provide expert guidance and support to cross-functional teams on quality-related matters.
- Participate in external regulatory inspections and host regulatory auditors.
- Drive continuous improvement initiatives to enhance product quality and operational efficiency.
- Develop and deliver training programs on quality assurance best practices.
- Monitor industry trends and regulatory updates, ensuring the company remains compliant.
- Manage quality agreements with external partners and suppliers.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 10 years of progressive experience in Quality Assurance within the pharmaceutical industry.
- Extensive knowledge of pharmaceutical manufacturing processes, quality control, and regulatory affairs.
- Proven experience in leading and conducting GMP audits.
- Strong understanding of ICH guidelines and global regulatory requirements.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional attention to detail and commitment to quality.
- Superior written and verbal communication skills.
- Ability to work independently and manage multiple complex projects effectively in a remote environment.
- Experience with quality management software (e.g., TrackWise, LIMS).
- Must have a reliable internet connection and a suitable home office setup for this fully remote role .
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Lead Pharmaceutical QA/QC Specialist (Remote)
Posted 20 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 12 days ago
Job Viewed
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 5 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 21 days ago
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Job Description
Our client, a rapidly expanding pharmaceutical company, is actively seeking a meticulous and experienced Pharmaceutical Quality Control Specialist to join their team. This is a fully remote position, allowing you to contribute to critical quality assurance processes from anywhere. The ideal candidate will possess a strong understanding of Good Manufacturing Practices (GMP), quality management systems, and regulatory requirements within the pharmaceutical industry. You will be responsible for reviewing and analyzing laboratory data, ensuring that raw materials, in-process samples, and finished products meet stringent quality specifications and regulatory standards. This involves executing various analytical tests, interpreting results, and documenting all activities in accordance with established protocols. Your role will include performing stability studies, investigating out-of-specification (OOS) results, and contributing to the development and validation of analytical methods. You will collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure product quality and compliance throughout the product lifecycle. A key aspect of this role involves maintaining detailed and accurate records, preparing quality control reports, and participating in internal and external audits. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field is essential, along with a minimum of 4 years of progressive experience in pharmaceutical quality control or quality assurance. Hands-on experience with analytical instrumentation (e.g., HPLC, GC, UV-Vis spectrophotometry) and familiarity with relevant pharmacopeias (e.g., USP, EP) are required. Excellent analytical, problem-solving, and documentation skills are paramount. The ability to work independently, manage multiple tasks efficiently, and adhere strictly to deadlines in a remote setting is crucial. This role offers a fantastic opportunity to contribute to the development and delivery of safe and effective pharmaceutical products while enjoying the benefits of a remote work environment. The position is designated for individuals interested in the **Kakamega, Kakamega, KE** area, with the work conducted entirely remotely.
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Senior Pharmaceutical Quality Control Specialist
Posted 12 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a meticulous and experienced Senior Pharmaceutical Quality Control Specialist to join their team. This role is crucial in ensuring that all manufactured pharmaceutical products meet the highest standards of quality, safety, and efficacy. You will be responsible for conducting rigorous testing, analyzing results, and implementing quality control procedures throughout the production process. The ideal candidate will possess a strong understanding of Good Manufacturing Practices (GMP), regulatory requirements, and analytical laboratory techniques. This position involves a hybrid work model, offering a balance between in-office laboratory work and remote administrative tasks, such as data analysis, report generation, and protocol development. Responsibilities include performing in-process and finished product testing, maintaining laboratory equipment, validating test methods, and ensuring compliance with all relevant quality standards. You will also be involved in troubleshooting quality issues, collaborating with cross-functional teams, and contributing to continuous improvement initiatives. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field is required. Excellent analytical, problem-solving, and documentation skills are essential. The ability to work independently and as part of a team, both on-site and remotely, is vital. This is an excellent opportunity for a dedicated quality professional to contribute to the development and manufacturing of life-saving medicines and advance their career within a reputable organization.
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Pharmaceutical Quality Assurance Specialist
Posted 21 days ago
Job Viewed
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 21 days ago
Job Viewed
Job Description
Our client is seeking an accomplished Lead Pharmaceutical Quality Assurance Specialist to oversee and enhance their quality management systems, operating entirely remotely. This crucial role ensures that all pharmaceutical products and processes comply with stringent regulatory standards, internal policies, and customer requirements. You will be responsible for developing, implementing, and maintaining robust quality assurance programs, conducting thorough audits, and leading investigations into deviations and non-conformities. The ideal candidate will possess a strong background in pharmaceutical sciences, quality control, or a related field, with extensive experience in GMP (Good Manufacturing Practices) and regulatory compliance. Responsibilities include managing quality documentation, coordinating quality review boards, and collaborating with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to drive quality initiatives. You will also be responsible for training and mentoring junior QA staff, fostering a culture of quality excellence throughout the organization. This position demands exceptional analytical and problem-solving skills, meticulous attention to detail, and outstanding communication and interpersonal abilities to effectively influence and collaborate in a remote setting. You will play a pivotal role in ensuring the safety, efficacy, and integrity of our pharmaceutical products, thereby safeguarding patient health and maintaining the company's reputation. Experience with pharmaceutical quality systems software and a thorough understanding of global regulatory requirements (FDA, EMA, etc.) are essential. This is an unparalleled opportunity for a dedicated QA professional to lead significant quality assurance efforts, drive continuous improvement, and contribute to the development of life-saving medicines in a challenging and rewarding remote role. If you are passionate about pharmaceutical quality and possess the leadership expertise to excel, we encourage you to apply.
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Remote Sanitation Supervisor - Quality Assurance
Posted 17 days ago
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Job Description
Our client is seeking a meticulous and proactive Remote Sanitation Supervisor to oversee and ensure high standards of cleanliness and sanitation across their facilities. This role is entirely remote, focusing on quality assurance, process development, and remote team guidance. You will be responsible for developing, implementing, and monitoring sanitation protocols and best practices to maintain a safe and hygienic environment. The ideal candidate will have a strong background in sanitation management, infection control, or a related field. Your duties will include creating detailed sanitation checklists, conducting remote audits and inspections of cleaning procedures, and analyzing data to identify areas for improvement. You will train and guide on-site cleaning staff remotely, ensuring they understand and adhere to established standards. Developing comprehensive training materials and providing ongoing support are key aspects of this position. Collaboration with facility managers and operational teams to address any sanitation-related concerns or challenges is essential. You will also stay updated on industry regulations, emerging hygiene technologies, and best practices in sanitation management. This position requires excellent organizational skills, attention to detail, and the ability to communicate effectively across different teams and locations. The successful candidate will be a self-starter, capable of working independently and managing multiple projects simultaneously in a remote work setting. This is a unique opportunity to contribute significantly to public health and safety by ensuring optimal sanitation standards through remote oversight and strategic planning.
Responsibilities:
Qualifications:
Responsibilities:
- Develop and implement comprehensive sanitation protocols and procedures.
- Conduct remote audits and quality assessments of cleaning operations.
- Train and guide on-site cleaning staff on best practices and standards.
- Analyze sanitation data and identify areas for improvement.
- Ensure compliance with health, safety, and sanitation regulations.
- Develop and update training materials for cleaning staff.
- Collaborate with facility management on sanitation-related issues.
- Stay informed about new sanitation technologies and industry trends.
- Maintain detailed records of audits, training, and corrective actions.
Qualifications:
- Proven experience in sanitation management, environmental services, or a related field.
- Strong understanding of hygiene principles, infection control, and sanitation best practices.
- Experience in developing and implementing cleaning protocols.
- Excellent organizational and time management skills.
- Strong communication and interpersonal skills for remote interaction.
- Ability to work independently and manage multiple priorities in a remote environment.
- Proficiency in using digital tools for reporting and communication.
- Detail-oriented with a commitment to quality assurance.
- High school diploma required; Bachelor's degree in a related field is a plus.
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Remote Senior Pharmaceutical Quality Control Specialist
Posted 21 days ago
Job Viewed
Job Description
Our client, a reputable pharmaceutical manufacturing organization, is seeking a highly diligent and experienced Senior Pharmaceutical Quality Control Specialist to join our fully remote team. This role is essential for ensuring the integrity, safety, and efficacy of pharmaceutical products through rigorous testing and adherence to quality standards. You will be responsible for developing, validating, and implementing analytical test methods for raw materials, in-process samples, and finished products. This involves performing a wide range of analytical techniques, including HPLC, GC, spectroscopy (UV-Vis, IR, AA), and wet chemistry methods. Meticulous documentation of all testing procedures, results, and deviations is paramount, adhering strictly to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). You will also participate in the investigation of out-of-specification (OOS) results, identify root causes, and implement corrective and preventive actions (CAPA). Collaboration with formulation scientists, production teams, and regulatory affairs personnel is crucial, requiring strong remote communication skills. The ideal candidate will possess a thorough understanding of pharmacopeial standards (e.g., USP, EP, BP) and regulatory guidelines. This fully remote position offers the flexibility to work from your own location within Kenya, promoting an excellent work-life balance while contributing to a vital industry. You will play a key role in maintaining the quality systems that underpin our client’s commitment to producing high-quality pharmaceuticals. We are seeking a detail-oriented professional with strong analytical acumen and a proactive approach to quality assurance. Your ability to independently manage testing schedules, interpret complex data, and ensure compliance in a virtual environment will be critical. This is an ideal opportunity for a seasoned QC professional looking to apply their expertise in a flexible, remote-working capacity.
Responsibilities:
Responsibilities:
- Perform analytical testing on raw materials, intermediates, and finished pharmaceutical products.
- Develop, validate, and transfer analytical methods.
- Operate and maintain analytical instrumentation (HPLC, GC, Spectrophotometers, etc.).
- Document all testing activities accurately and in compliance with GMP/GLP.
- Investigate out-of-specification (OOS) results and implement CAPA.
- Review and approve batch records and analytical data.
- Ensure compliance with pharmacopeial standards and regulatory requirements.
- Collaborate with cross-functional teams to resolve quality issues.
- Contribute to the continuous improvement of QC processes and systems.
- Maintain laboratory equipment calibration and qualification logs.
- Bachelor's or Master's degree in Chemistry, Pharmacy, or a related life science field.
- Minimum of 6 years of experience in pharmaceutical quality control.
- Extensive hands-on experience with analytical techniques (HPLC, GC, UV-Vis, etc.).
- Strong knowledge of GMP, GLP, and regulatory guidelines.
- Experience with method validation and OOS investigations.
- Excellent attention to detail and accuracy in documentation.
- Strong problem-solving and analytical skills.
- Effective remote communication and interpersonal skills.
- Ability to work independently and manage priorities in a remote setting.
- Must be based in Kenya and available to work within Kenyan business hours.
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