1047 Quality Assurance Specialists jobs in Nairobi
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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Senior Pharmaceutical Quality Assurance Specialist
Posted 16 days ago
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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.
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Remote Pharmaceutical Quality Assurance Specialist
Posted 18 days ago
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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.
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Senior Pharmaceutical Quality Assurance Specialist (Remote)
Posted 8 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a meticulous and experienced Senior Pharmaceutical Quality Assurance Specialist to join their global, remote-based team. This role is crucial for ensuring that all pharmaceutical products meet stringent quality standards and comply with regulatory requirements. This is a fully remote position, offering the flexibility to work from any approved location within Kenya.
Key Responsibilities Include:
The ideal candidate will hold a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Master's degree is a plus. A minimum of 5-7 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry is mandatory. Thorough knowledge of cGMP, regulatory requirements (e.g., FDA, EMA), and quality risk management principles is essential. Excellent analytical, problem-solving, and documentation skills are required. Strong written and verbal communication skills are paramount. As this is a fully remote role, a high degree of self-motivation, attention to detail, and the ability to work independently with minimal supervision are crucial. This role supports quality operations relevant to the Mombasa, Mombasa, KE region.
This is an excellent opportunity for a seasoned QA professional to contribute to critical quality functions in a dynamic and flexible remote work environment. If you are dedicated to ensuring pharmaceutical product quality and compliance, we encourage you to apply.
Key Responsibilities Include:
- Developing, implementing, and maintaining quality assurance systems and procedures in accordance with cGMP, ICH guidelines, and other relevant regulations.
- Reviewing and approving manufacturing batch records, analytical data, and validation protocols.
- Conducting internal audits and participating in external regulatory inspections.
- Investigating deviations, out-of-specification (OOS) results, and customer complaints, and implementing corrective and preventive actions (CAPAs).
- Managing change control processes and ensuring all changes are properly assessed and documented.
- Preparing and submitting quality-related documentation for regulatory filings.
- Training QA/QC personnel and other relevant staff on quality systems and compliance.
- Monitoring and assessing supplier quality performance.
- Staying current with evolving pharmaceutical regulations and industry best practices.
- Contributing to the continuous improvement of the Quality Management System (QMS).
The ideal candidate will hold a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Master's degree is a plus. A minimum of 5-7 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry is mandatory. Thorough knowledge of cGMP, regulatory requirements (e.g., FDA, EMA), and quality risk management principles is essential. Excellent analytical, problem-solving, and documentation skills are required. Strong written and verbal communication skills are paramount. As this is a fully remote role, a high degree of self-motivation, attention to detail, and the ability to work independently with minimal supervision are crucial. This role supports quality operations relevant to the Mombasa, Mombasa, KE region.
This is an excellent opportunity for a seasoned QA professional to contribute to critical quality functions in a dynamic and flexible remote work environment. If you are dedicated to ensuring pharmaceutical product quality and compliance, we encourage you to apply.
This advertiser has chosen not to accept applicants from your region.
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Remote Senior Pharmaceutical Quality Assurance Specialist
Posted 18 days ago
Job Viewed
Job Description
Our client, a leader in pharmaceutical innovation, is seeking a highly experienced Senior Pharmaceutical Quality Assurance Specialist to join their global, remote-first team. This position is critical to ensuring the highest standards of quality and compliance throughout the drug development and manufacturing lifecycle. You will be responsible for developing, implementing, and maintaining robust quality management systems, ensuring adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory requirements. The ideal candidate will possess a deep understanding of pharmaceutical quality principles, regulatory affairs, and risk management. You will play a key role in audits, investigations, and the continuous improvement of quality processes.
Key Responsibilities:
Key Responsibilities:
- Develop, implement, and manage the company's Quality Management System (QMS) to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH guidelines).
- Oversee and participate in internal and external audits of manufacturing sites, contract manufacturers, and suppliers.
- Review and approve critical quality documents, including batch records, validation protocols, SOPs, and change controls.
- Lead and participate in investigations of deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out-of-Specification) results.
- Assess and manage quality risks associated with product development, manufacturing, and supply chain.
- Provide training and guidance to internal teams and external partners on quality assurance principles and regulatory requirements.
- Monitor and analyze quality metrics to identify trends and areas for improvement.
- Collaborate with regulatory affairs to ensure compliance with all applicable regulations.
- Contribute to the development and continuous improvement of quality policies and procedures.
- Stay current with evolving regulatory landscapes and industry best practices in pharmaceutical quality assurance.
- Manage quality aspects of product lifecycle, from development through post-market surveillance.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance and Quality Control.
- Extensive knowledge of GMP, GLP, GCP, and other relevant pharmaceutical quality systems and regulations.
- Proven experience in conducting and managing audits, investigations, and risk assessments.
- Strong understanding of pharmaceutical manufacturing processes and product development.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to communicate complex technical and regulatory information clearly.
- Ability to work independently, manage multiple projects, and prioritize effectively in a remote setting.
- Proficiency in quality management software and standard office applications.
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4
Senior Commercial Cleaner - Remote Trainer/Supervisor
Posted 8 days ago
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Job Description
Our client, a prominent provider of commercial cleaning services, is seeking an experienced Senior Commercial Cleaner to transition into a Trainer/Supervisor role. While this role involves significant on-site presence at client locations and within our operational hubs, there will be a hybrid element allowing for remote administrative tasks and training development. You will be responsible for training new cleaning staff on best practices, safety protocols, and the effective use of cleaning equipment and chemicals. As a supervisor, you will oversee cleaning operations, conduct quality control inspections, and ensure client satisfaction. This role requires a deep understanding of commercial cleaning techniques, a commitment to maintaining the highest standards of hygiene, and a passion for mentoring others. Key responsibilities include developing training modules, conducting hands-on training sessions, scheduling and managing cleaning teams, and addressing any operational challenges that arise. You will be expected to stay updated on industry trends and new cleaning technologies. The ideal candidate possesses exceptional leadership and communication skills, with the ability to motivate and guide a team effectively. A strong understanding of health and safety regulations related to cleaning is crucial. Previous experience in a supervisory or training role within the cleaning industry is highly desirable. A proven track record as a highly skilled commercial cleaner is a prerequisite. This position offers a fantastic opportunity to leverage your expertise in a leadership capacity, contributing to the growth and development of our cleaning division.
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5
Senior Quality Assurance Engineer - Manufacturing (Remote)
Posted 18 days ago
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Job Description
Our client, a leader in high-precision manufacturing, is seeking an experienced Senior Quality Assurance Engineer to join their fully remote team. This critical role focuses on establishing and maintaining robust quality control systems to ensure the highest standards of product integrity. The ideal candidate will have a strong background in quality management, statistical process control, and regulatory compliance within a manufacturing environment. You will be responsible for developing quality plans, conducting audits, analyzing quality data, and implementing corrective actions to prevent defects and drive continuous improvement. This position requires meticulous attention to detail, strong analytical skills, and the ability to collaborate effectively with production, engineering, and management teams in a virtual setting.
Key Responsibilities:
Qualifications:
This is an exceptional opportunity for a skilled Quality Assurance professional to play a key role in ensuring product excellence within a leading manufacturing company that fully supports remote work. Join a team dedicated to innovation and continuous improvement.
Key Responsibilities:
- Develop, implement, and maintain comprehensive quality assurance plans and procedures for manufacturing processes.
- Ensure compliance with relevant industry standards (e.g., ISO 9001, GMP) and customer specifications.
- Conduct regular internal audits of manufacturing processes, equipment, and documentation to assess compliance and identify areas for improvement.
- Analyze quality data, identify root causes of defects, and implement effective corrective and preventive actions (CAPA).
- Develop and manage statistical process control (SPC) programs to monitor and control production variability.
- Collaborate with engineering and production teams to resolve quality issues and implement process improvements.
- Oversee the calibration and maintenance of quality control equipment.
- Prepare detailed quality reports, including trend analysis, performance metrics, and audit findings.
- Train and guide quality control personnel on inspection techniques, procedures, and quality standards.
- Stay current with advancements in quality management systems and manufacturing technologies.
- Lead cross-functional teams in problem-solving initiatives related to quality.
- Champion a culture of quality throughout the organization.
Qualifications:
- Bachelor's degree in Engineering (Mechanical, Industrial, Manufacturing), Quality Management, or a related field.
- A minimum of 7 years of experience in Quality Assurance or Quality Control within a manufacturing environment.
- Proven experience with quality management systems (e.g., ISO 9001, AS9100, IATF 16949).
- Strong knowledge of statistical process control (SPC), Six Sigma, and Lean Manufacturing principles.
- Experience with various inspection techniques and measurement tools.
- Proficiency in quality analysis software and tools.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong written and verbal communication skills, with the ability to document findings clearly and concisely.
- Ability to work independently, manage time effectively, and lead quality initiatives in a remote setting.
- Attention to detail and a commitment to excellence.
- Experience with auditing and certification processes is highly desirable.
This is an exceptional opportunity for a skilled Quality Assurance professional to play a key role in ensuring product excellence within a leading manufacturing company that fully supports remote work. Join a team dedicated to innovation and continuous improvement.
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6
Lead Technical Trainer - Advanced Manufacturing
Posted 1 day ago
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Job Description
Our client, a renowned leader in vocational training and skills development, is looking for an experienced Lead Technical Trainer to join our remote apprenticeship program. This exciting opportunity focuses on delivering cutting-edge training in advanced manufacturing technologies. You will be responsible for developing and updating comprehensive training modules, creating engaging learning materials, and delivering high-quality instruction to apprentices across various manufacturing disciplines, including CNC machining, robotics, and automation. Your expertise will extend to assessing apprentice progress, providing constructive feedback, and ensuring training programs meet industry standards and employer needs. A key aspect of this role involves staying current with the latest advancements in manufacturing technology and incorporating them into the curriculum. You will also play a role in curriculum design and quality assurance, working closely with industry partners to ensure relevance and effectiveness. The ideal candidate will have a strong background in advanced manufacturing processes and a passion for teaching and mentorship. Proven experience in developing and delivering technical training programs, preferably in an apprenticeship setting, is essential. A relevant technical certification or degree in a manufacturing-related field is highly desirable. Excellent communication, presentation, and interpersonal skills are required, along with the ability to manage learning effectively in a remote environment. You should be adept at utilizing various e-learning platforms and digital tools to enhance the learning experience. This is a chance to significantly shape the future workforce in a critical industrial sector, providing valuable skills and career pathways for aspiring technicians and engineers.
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7
Pharmaceutical Quality Assurance Manager
Posted 18 days ago
Job Viewed
Job Description
Our client is seeking a highly qualified and experienced Pharmaceutical Quality Assurance Manager to lead their quality systems and compliance efforts within a fully remote framework. This crucial 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 robust quality management systems, including SOPs, batch record review, deviation management, CAPA, change control, and internal audits. Key responsibilities include ensuring compliance with cGMP, FDA, and other relevant regulatory guidelines. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing processes, quality control methodologies, and regulatory affairs. Strong leadership, analytical, and problem-solving skills are essential. As this is a fully remote position, exceptional written and verbal communication skills are paramount for effective collaboration with manufacturing teams, R&D, and regulatory bodies across different locations. You must be self-motivated, detail-oriented, and capable of managing multiple complex projects with a high degree of accuracy. This role offers the significant opportunity to ensure the safety and efficacy of pharmaceutical products while working flexibly from anywhere. You will play a critical role in maintaining the integrity of the company's quality operations and fostering a culture of continuous quality improvement. A Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field is required. A Master's degree or relevant professional certifications are advantageous. A minimum of 7-10 years of progressive experience in pharmaceutical quality assurance and quality control, with a significant portion in a management or supervisory role, is essential. Experience with electronic quality management systems is a plus. This position is fully remote, supporting quality assurance operations that may be connected to Mombasa, Mombasa, KE . If you are a seasoned QA professional dedicated to upholding the highest standards in the pharmaceutical industry, we encourage you to apply.
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8
Principal Pharmaceutical Quality Assurance Engineer
Posted 3 days ago
Job Viewed
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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