2 Remote Lead Pharmaceutical Quality Assurance Specialist jobs in whatjobs
Remote Lead Pharmaceutical Quality Assurance Specialist
Posted 9 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.
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Remote Lead Pharmaceutical Quality Assurance Specialist
Posted 4 days ago
Job Viewed
Job Description
Our client is seeking a highly skilled and experienced Remote Lead Pharmaceutical Quality Assurance Specialist to join their dedicated team. This is a critical role focused on ensuring the highest standards of quality and compliance within pharmaceutical operations, all performed from a remote location. 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 guidelines. Your duties will include conducting virtual audits of manufacturing sites, reviewing batch records, investigating deviations and out-of-specification results, and managing change controls. You will also be instrumental in the preparation and submission of regulatory dossiers and responding to inquiries from health authorities. This position requires a thorough understanding of the pharmaceutical lifecycle, from drug development to commercialization. You will lead a team of quality assurance professionals, providing guidance, mentorship, and performance management, all within a remote work setting. The ideal candidate possesses exceptional analytical and problem-solving skills, meticulous attention to detail, and strong organizational abilities. Excellent written and verbal communication skills are essential for effective collaboration with internal teams, external partners, and regulatory bodies. You should be adept at interpreting complex technical data and regulatory requirements. This role demands a proactive approach to risk management and a commitment to continuous improvement in quality processes. The ability to work independently, manage multiple priorities, and meet strict deadlines is paramount. We are looking for a seasoned professional with a deep commitment to patient safety and product integrity. Your leadership will be crucial in upholding our client's reputation for excellence and compliance in the global pharmaceutical market. This fully remote opportunity offers the chance to significantly influence quality strategies and contribute to the development of life-saving medications. You will be at the forefront of ensuring that every product meets stringent quality benchmarks, safeguarding public health. Your expertise will be vital in navigating the evolving landscape of pharmaceutical regulations and quality standards.
This advertiser has chosen not to accept applicants from your region.
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