2 Lead Remote Pharmaceutical Quality Assurance Specialist jobs in Kenya
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.
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Lead Remote Pharmaceutical Quality Assurance Specialist
Posted 6 days ago
Job Viewed
Job Description
Our client is seeking a highly motivated and experienced Lead Remote Pharmaceutical Quality Assurance Specialist to ensure the highest standards of quality and compliance within their operations. This is a fully remote position, requiring a deep understanding of pharmaceutical regulations, Good Manufacturing Practices (GMP), and quality management systems. You will be responsible for developing, implementing, and maintaining robust quality assurance protocols across all relevant stages of drug development and manufacturing. Your expertise will be critical in conducting remote audits, reviewing documentation, and providing guidance on quality-related issues. The ideal candidate will possess a strong background in pharmaceutical sciences, extensive experience in QA/QC, and a proven ability to interpret and apply complex regulatory guidelines (e.g., FDA, EMA). Proficiency in quality management software and advanced virtual communication tools is essential for effective collaboration with internal teams and external partners. Responsibilities include identifying potential compliance risks, developing corrective and preventive actions (CAPA), and contributing to continuous improvement initiatives. We are looking for an individual with exceptional analytical skills, meticulous attention to detail, and the ability to communicate complex technical information clearly and concisely. The capacity to lead virtual QA teams and drive a culture of quality and compliance in a remote setting is crucial. This is a significant opportunity to contribute to patient safety and the integrity of pharmaceutical products by applying your expertise from anywhere. Join our client's dedicated team and play a pivotal role in shaping the future of pharmaceutical quality assurance. The candidate must be proactive in staying updated with evolving regulatory landscapes and industry best practices.
This advertiser has chosen not to accept applicants from your region.
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