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 Africa for more than thirty years. The Shalina Group is headquartered in Dubai and we have operating offices in Nigeria, Zambia, The Democratic Republic of Congo, Angola, Ghana, Republic of South Sudan, Kenya, Cameroon, Central African Republic, India and China. We employ over one thousand people worldwide. Shalina Group’s second business vertical is Shalina Resources, a minerals company located in Southern DRC.
Shalina Healthcare is a market leader and we offer a wide basket of more than two hundred and fifty products. We participate in both the prescription and over-the-counter categories in a broad range of therapeutic groups, including anti-malarials, antibiotics, anti-inflammatory and nutrition. Our range includes both generic and branded generic products. Shalina Healthcare also offers a range of consumer products in the hygiene segment, most notable with our brand Germol.
Our reputation as reliable manufacturers and distributors of healthcare products is reinforced every time we launch a new product into the market. It may be the first time the drug has been launched in the remote regions that we serve and we support this with regular continuing medical education campaigns for the doctors and nurses.
Over the last thirty years, Shalina’s reputation as a quality healthcare provider in Africa has been well accepted by the medical community, who has no hesitation in prescribing Shalina products to their patients. We work closely with the local communities to help people live longer and healthier lives. None of this would be possible without the immense contribution of our dedicated employees.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