Associate Manager - Quality Assurance
Shalina Healthcare
Job Description
- The QA Associate Manager is responsible for supporting the implementation and maintenance of the Quality Management System (QMS) in compliance with regulatory requirements such as GMP, WHO, and NAFDAC standards.
- The role ensures that all manufacturing processes, documentation, and quality systems meet established standards and that products are consistently produced and controlled to quality specifications.
Key Responsibilities
- Support the QA Manager in overseeing all Quality Assurance activities within the manufacturing facility.
- Ensure compliance with cGMP, WHO guidelines, and NAFDAC regulations.
- Review and approve Standard Operating Procedures (SOPs), batch manufacturing records (BMR), and batch packaging records (BPR).
- Monitor and ensure proper documentation practices (GDP) across departments.
- Coordinate and participate in internal and external audits (regulatory, customer, and certification audits).
- Manage deviations, CAPA (Corrective and Preventive Actions), change controls, and investigations.
- Oversee validation and qualification activities (process validation, cleaning validation, equipment qualification).
- Ensure proper training and compliance of staff on quality systems and SOPs.
- Review and approve product release documentation and support batch disposition.
- Collaborate with Production, QC, Engineering, and Warehouse to ensure quality compliance.
- Monitor environmental conditions and ensure compliance with required standards.
- Maintain and improve the Quality Management System (QMS).
- Support regulatory inspections and ensure timely closure of audit findings.
Qualifications & Experience
- Bachelor’s Degree in pharmacy, Microbiology, Biochemistry, Chemistry, or related field.
- 10–15 years experience in pharmaceutical manufacturing, with at least 2–3 years in a supervisory / lead role in QA.
- Strong knowledge of GMP, GDP, and regulatory requirements (NAFDAC, WHO, ISO).
- Experience in handling audits and regulatory inspections.
Application Closing Date
Not Specified.
How to Apply
Interested and qualified candidates should:
Click here to apply online
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Vacancy posted 6 hours ago
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