Associate Manager Quality Assurance (external Manufacturing) At Shalina Healthcare
full-time
Job Description
The Associate Manager - Quality Assurance (External Manufacturing) is responsible for overseeing and ensuring compliance of all externally manufactured pharmaceutical products with regulatory requirements, company quality standards, and GMP guidelines.
This role involves managing contract manufacturing organizations (CMOs), conducting audits, reviewing documentation, and ensuring product quality throughout the supply chain.
Key Responsibilities
External Manufacturing Oversight:
Ensure all contract manufacturers comply with GMP, regulatory, and company quality standards.
Act as the primary QA contact for all external manufacturing partners.
Vendor Qualification & Audits:
Perform qualification, requalification, and periodic audits of CMOs, suppliers, and service providers.
Prepare audit reports and follow up on corrective and preventive actions (CAPAs).
Batch Documentation & Release:
Review and approve batch manufacturing records, analytical reports, and related documents from CMOs.
Support or authorize batch release in compliance with regulatory requirements.
Quality Systems Management:
Ensure implementation of quality systems at external sites (deviations, change controls, CAPA, OOS/OOT).
Monitor and track quality metrics for external manufacturing operations.
Regulatory Compliance:
Ensure products meet NAFDAC, WHO, and other applicable regulatory requirements.
Support regulatory submissions and inspections related to external manufacturing.
Deviation & Investigation Handling:
Review and approve deviations, investigations, and CAPAs from external partners.
Ensure timely closure and effectiveness of corrective actions.
Change Control Management:
Evaluate and approve changes related to materials, processes, and equipment at CMOs.
Assess impact on product quality and regulatory compliance.
Qualifications
Experience: 8 - 10 years of experience in Quality Assurance within the pharmaceutical industry
Experience with external manufacturing or contract manufacturing organizations (CMOs) is highly preferred
Skills & Competencies:
Strong knowledge of GMP, GDP, and regulatory requirements (NAFDAC, WHO,)
Experience in auditing and vendor management
Excellent documentation review and attention to detail
Strong analytical and problem-solving skills
Effective communication and stakeholder management
Ability to work independently and manage multiple priorities