Associate Manager-Quality Assurance

Shalina Healthcare

Remote

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.
Minimum of 10–15years 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.