6,785 Lead Pharmaceutical Quality Assurance Specialist Remote jobs in Kenya
Lead Pharmaceutical Quality Assurance Specialist (Remote)
Posted 21 days ago
Job Viewed
Job Description
Our client is seeking a highly qualified and experienced Lead Pharmaceutical Quality Assurance Specialist to join their global remote team. This senior role will be instrumental in ensuring compliance with stringent pharmaceutical regulations and industry best practices across all quality assurance functions. You will lead and mentor a team of QA professionals, oversee the development and implementation of quality management systems, and drive continuous improvement initiatives. Key responsibilities include developing and executing quality assurance strategies, establishing QA policies and procedures, and ensuring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant regulatory guidelines. You will be responsible for conducting internal audits, managing external regulatory inspections, and investigating deviations and CAPAs (Corrective and Preventive Actions). Collaboration with cross-functional teams, including R&D, manufacturing, and regulatory affairs, is crucial to ensure product quality and integrity throughout the lifecycle. The ideal candidate will possess a deep understanding of the pharmaceutical industry, regulatory landscapes (FDA, EMA, etc.), and quality control principles. A proven track record in leading QA teams and managing complex QA projects is required. Excellent analytical, problem-solving, and decision-making skills are paramount. Strong communication and interpersonal skills are essential for effective team leadership and stakeholder engagement. This is a fully remote position, requiring a proactive, detail-oriented individual with the ability to work independently and manage multiple priorities effectively. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field is mandatory. Extensive experience in pharmaceutical quality assurance is essential.
This advertiser has chosen not to accept applicants from your region.
0
Lead Remote Pharmaceutical Quality Assurance Specialist
Posted 21 days ago
Job Viewed
Job Description
Our client, a reputable pharmaceutical company committed to improving global health, is seeking a Lead Remote Pharmaceutical Quality Assurance Specialist. This is a critical, fully remote role responsible for ensuring the highest standards of quality and compliance across all pharmaceutical development and manufacturing processes. The successful candidate will lead QA initiatives, conduct audits, and implement robust quality management systems. This position requires a deep understanding of pharmaceutical regulations (GMP, GCP, GLP), excellent analytical skills, and the ability to effectively manage quality processes and teams remotely.
Key Responsibilities:
Key Responsibilities:
- Develop, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with global regulatory requirements.
- Conduct internal and external audits of manufacturing sites, contract manufacturing organizations (CMOs), and suppliers to ensure compliance.
- Review and approve critical quality documents, including batch records, validation protocols, and SOPs.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and change controls, ensuring timely and effective resolution.
- Monitor and analyze quality metrics and trends, reporting key performance indicators (KPIs) to senior management.
- Provide expert guidance on GMP, GCP, and GLP compliance to cross-functional teams.
- Lead and mentor junior QA professionals in a remote working environment.
- Participate in regulatory inspections and provide necessary support and documentation.
- Contribute to risk management activities and the development of mitigation strategies.
- Stay updated on evolving pharmaceutical regulations and industry best practices.
- Manage the lifecycle of quality documentation and records.
- Collaborate effectively with R&D, manufacturing, regulatory affairs, and other departments remotely.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 8 years of progressive experience in Pharmaceutical Quality Assurance/Quality Control.
- Extensive knowledge of GMP, GCP, GLP, and other relevant pharmaceutical regulations (e.g., FDA, EMA).
- Proven experience in conducting audits, managing deviations, and implementing CAPAs.
- Strong understanding of pharmaceutical manufacturing processes and analytical testing.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with the ability to present complex information clearly.
- Demonstrated leadership abilities and experience in managing teams remotely.
- Proficiency in QMS software and digital documentation systems.
- Ability to work independently, manage priorities, and meet strict deadlines.
- Detail-oriented with a commitment to ensuring product quality and patient safety.
This advertiser has chosen not to accept applicants from your region.
1
Remote Lead Pharmaceutical Quality Assurance Specialist
Posted 10 days ago
Job Viewed
Job Description
Our client is seeking a highly meticulous and experienced Remote Lead Pharmaceutical Quality Assurance Specialist to join their robust, fully remote Quality Assurance department. This critical role is responsible for ensuring that all pharmaceutical products meet the highest standards of quality, safety, and efficacy. The ideal candidate will possess extensive knowledge of pharmaceutical manufacturing processes, regulatory guidelines (e.g., GMP, GDP), and quality management systems. You will lead a team of QA professionals, overseeing the implementation and continuous improvement of QA strategies and processes. Key responsibilities include developing and executing quality control plans, conducting internal audits, managing deviations and CAPAs (Corrective and Preventive Actions), and ensuring compliance with all relevant health authority regulations. The Lead QA Specialist will play a vital role in product lifecycle management, from raw material testing and in-process control to finished product release. Strong analytical skills, meticulous attention to detail, and excellent problem-solving abilities are essential for identifying and mitigating potential quality risks. The incumbent will also be responsible for training QA staff, collaborating with cross-functional teams (e.g., R&D, Manufacturing, Regulatory Affairs), and preparing documentation for regulatory submissions and inspections. This position offers a challenging and rewarding opportunity to contribute to patient safety and public health from a remote work setting. While this role is entirely remote, it directly supports and influences the quality control operations that are managed by our client's facilities in Eldoret, Uasin Gishu, KE .
Responsibilities:
Responsibilities:
- Lead the development, implementation, and maintenance of the Quality Management System (QMS).
- Ensure compliance with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant regulations.
- Oversee the investigation of deviations, out-of-specifications (OOS), and customer complaints.
- Manage Corrective and Preventive Actions (CAPA) implementation and effectiveness.
- Conduct internal audits and support external regulatory inspections.
- Review and approve batch records, validation reports, and other quality-related documents.
- Develop and implement quality control strategies and testing protocols.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality.
- Train and mentor junior QA personnel.
- Monitor industry trends and regulatory changes affecting pharmaceutical quality.
- Contribute to the continuous improvement of quality processes and systems.
- Manage supplier quality and qualification programs.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related science field.
- Minimum of 7 years of experience in Pharmaceutical Quality Assurance/Quality Control.
- Proven experience in a leadership or supervisory role within QA.
- In-depth knowledge of GMP/GDP regulations and guidelines.
- Strong understanding of pharmaceutical manufacturing processes and analytical testing.
- Experience with QMS, deviation management, and CAPA systems.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong written and verbal communication skills.
- Proficiency in quality documentation and regulatory submission support.
- Ability to work independently and effectively manage workload in a remote environment.
This advertiser has chosen not to accept applicants from your region.
2
Lead Pharmaceutical QA/QC Specialist (Remote)
Posted 20 days ago
Job Viewed
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.
This advertiser has chosen not to accept applicants from your region.
3
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.
This advertiser has chosen not to accept applicants from your region.
4
Principal Pharmaceutical Quality Assurance Engineer
Posted 5 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.
This advertiser has chosen not to accept applicants from your region.
5
Remote Pharmaceutical Quality Control Specialist
Posted 21 days ago
Job Viewed
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.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Lead pharmaceutical quality assurance specialist remote Jobs in Kenya !
6
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.
This advertiser has chosen not to accept applicants from your region.
7
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.
This advertiser has chosen not to accept applicants from your region.
8
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.
This advertiser has chosen not to accept applicants from your region.
9