Associate Manager – Quality Assurance (External Manufacturing) at Shalina Healthcare

• 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