Associate Manager-QA (External Manufacturing) at Shalina Healthcare

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• • Associate Manager-QA (External Manufacturing) at Shalina Healthcare
  • View Jobs in NGO / Non-Profit Associations / View Jobs at Shalina Healthcare

  Posted: Jul 14, 2026

  Deadline: Not specified

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  Shalina Healthcare is a market leader in making quality healthcare products affordable and available across Africa. We achieve this by sourcing from WHO-approved production facilities in India and China and by focusing on our first-class distribution expertise. Shalina Healthcare is privately owned and part of the Shalina Group. We have been operating in...
  

  Associate Manager-QA (External Manufacturing)

  • Job Type Full Time
  • Qualification BA/BSc/HND
  • Experience 8 - 10 years
  • Location Ogun
  • Job Field Manufacturing&nbsp

  About the job

  • 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.
  • 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

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  Method of Application

  Interested and qualified? Go to Shalina Healthcare on myshalina.darwinbox.com to apply

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Average Salary at Shalina Healthcare

₦ 118K from 8 employees

Checkout salary structure of Shalina Healthcare »

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