6,650 Qc Specialist jobs in Kenya
Lead Pharmaceutical QA/QC Specialist (Remote)
Posted 21 days ago
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Job Description
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.
Senior Quality Assurance Manager - Pharmaceutical Manufacturing
Posted 22 days ago
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Quality Assurance Manager - Manufacturing Standards
Posted 14 days ago
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Lead Quality Assurance Manager - Manufacturing
Posted 5 days ago
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Pharmaceutical Quality Assurance Manager
Posted 22 days ago
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Job Description
Responsibilities:
- Develop, implement, and maintain robust Quality Management Systems (QMS) in compliance with cGMP, FDA, and other relevant regulatory guidelines.
- Conduct internal audits and inspections to assess adherence to quality standards and identify areas for improvement.
- Manage external audits and inspections by regulatory authorities and partners.
- Oversee the review and approval of batch records, validation protocols, and change controls.
- Investigate deviations, CAPAs (Corrective and Preventive Actions), and customer complaints, ensuring timely and effective resolutions.
- Develop and deliver quality assurance training programs for relevant personnel.
- Monitor and analyze quality metrics and trends to identify systemic issues and opportunities for process enhancement.
- Ensure that all pharmaceutical manufacturing and laboratory operations meet required quality standards.
- Collaborate with R&D, Manufacturing, and Regulatory Affairs departments to ensure product quality throughout the lifecycle.
- Stay updated on evolving regulatory requirements and industry best practices in pharmaceutical quality assurance.
- Manage the quality review process for new product introductions and lifecycle management.
- Lead continuous improvement initiatives within the quality assurance function.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is preferred.
- Minimum of 6 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry.
- In-depth knowledge of cGMP, ICH guidelines, and regulatory requirements (e.g., FDA, EMA).
- Proven experience in developing and implementing QMS, conducting audits, and managing 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 communicate effectively with cross-functional teams and regulatory bodies.
- Demonstrated leadership capabilities and the ability to work independently in a remote environment.
- Proficiency in quality management software and tools.
- Attention to detail and a commitment to maintaining the highest quality standards.
Remote Quality Assurance Manager (Manufacturing)
Posted 16 days ago
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Senior Quality Assurance Manager - Manufacturing
Posted 22 days ago
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Job Description
Responsibilities:
- Develop, implement, and manage the company's Quality Management System (QMS) in accordance with relevant standards (e.g., ISO 9001).
- Establish and oversee quality control processes throughout the manufacturing lifecycle, from raw material inspection to finished product release.
- Lead and mentor a remote team of quality assurance professionals, providing guidance and support.
- Conduct regular internal audits and assessments to ensure compliance with quality standards and procedures.
- Analyze quality data, identify trends, and implement corrective and preventive actions (CAPA) to address non-conformities.
- Collaborate with production, engineering, and R&D teams to resolve quality issues and implement process improvements.
- Develop and maintain quality documentation, including SOPs, work instructions, and inspection protocols.
- Manage customer complaints and feedback related to product quality, ensuring timely and effective resolution.
- Stay up-to-date with industry best practices, regulatory changes, and emerging quality assurance technologies.
- Facilitate external audits by regulatory bodies and customers.
- Champion a company-wide commitment to quality and continuous improvement.
- Bachelor's degree in Engineering, Science, Business Administration, or a related field. A Master's degree or relevant professional certification is a plus.
- Minimum of 7 years of progressive experience in quality assurance and quality management, preferably within the manufacturing sector.
- Demonstrated experience in developing, implementing, and maintaining QMS, including ISO 9001 certification.
- Strong understanding of quality control methodologies, statistical process control (SPC), and root cause analysis techniques.
- Proven ability to lead and manage remote teams effectively.
- Excellent analytical, problem-solving, and decision-making skills.
- Exceptional communication, interpersonal, and leadership abilities.
- Experience with quality management software and tools.
- Ability to work independently and manage multiple priorities in a remote environment.
- Commitment to continuous improvement and a passion for ensuring product excellence.
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Lead Pharmaceutical Quality Assurance Manager
Posted 22 days ago
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Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in line with global regulatory standards (e.g., GMP, ISO).
- Lead and mentor a team of Quality Assurance professionals in a remote setting.
- Oversee and conduct internal and external audits of manufacturing facilities, suppliers, and processes.
- Manage deviation investigations, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA).
- Ensure compliance with all relevant pharmaceutical regulations and guidelines.
- Review and approve batch records, validation protocols, and other critical quality documents.
- Manage product release processes to ensure products meet all quality and regulatory requirements.
- Develop and deliver quality training programs for staff.
- Act as a key point of contact for regulatory inspections and agency interactions.
- Drive continuous improvement initiatives within the QA department and across the organization.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
- Minimum of 7 years of progressive experience in Pharmaceutical Quality Assurance, with at least 2 years in a leadership role.
- In-depth knowledge of GMP, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in auditing, CAPA management, and QMS implementation.
- Strong analytical, problem-solving, and decision-making skills.
- Excellent communication, leadership, and interpersonal skills.
- Proficiency in quality management software and tools.
- Ability to manage projects and teams effectively in a remote environment.
Principal Pharmaceutical Quality Assurance Manager
Posted 22 days ago
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Senior Pharmaceutical Quality Assurance Manager
Posted 22 days ago
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