About Shalina Healthcare:
Shalina Healthcare is one of the largest pharmaceutical companies in sub-Saharan Africa. For the last 40 years we have made it our mission to provide quality medicines to those who need it the most. We manufacture and distribute branded prescription and over-the-counter pharmaceutical and consumer products, across a broad range of therapeutic groups, including anti-malarial, antibiotics, anti-inflammatory and nutrition. We have a track record few can match and our brands are among the most trusted in Africa.
We are proud of our history and have big ambitions for the future. Our vision for 2030 is to be the health champion of Sub-Saharan Africa. To achieve this, we are looking for the right people to join us and create a lasting impact not just within our company but on the communities we serve.
Everyone in our company has a crucial role to play, and we are looking for people who identify with our Core Values and are as passionate about our Mission as we are.
The Global Supply Organisation is a multi-continental Function that comprises of the entire Value Chain from product conceptualization to delivery to the commercial front. Within the Global Supply Organization are included; Research & Development, Project Management, Manufacturing, Quality, Supply Chain Management and Logistics.

Role: Associate Manager - External Quality
Base location: Navi Mumbai (Mahape)
Reporting to : Sr. Manager - Quality

Role Overview
The Associate Manager – External Quality will be responsible for overseeing quality compliance and operations across contract manufacturing organizations (CMOs). The role ensures adherence to GMP standards, supports product quality, and drives effective coordination between internal and external stakeholders.
What to expect:




Oversee and monitor quality operations at contract manufacturing sites across the assigned region
Act as the regional quality representative for compliance and quality-related matters
Perform finished goods (FG) inspection, batch record review, and batch release activities
Review finished product data to support new third-party product launches
Ensure in-process quality assurance (IPQA) across dosage forms including: Tablets and capsules (OSD), Oral liquids, External preparations & Sterile formulations
Monitor shop floor activities to ensure compliance with GMP standards
Execute and review process validation and stability studies
Prepare Annual Product Quality Reviews (APQR)
Witness manufacturing processes and finished product analysis
Conduct quality audits of contract manufacturers and track compliance actions
Manage relationships and coordination with CMOs

Preferred Candidate :
10–12 years of relevant experience in pharmaceutical quality operations
Solid exposure to GMP environments and regulatory inspections
Hands-on experience in shop floor quality operations
Willingness to travel extensively across India and internationally
Ability to make independent, real-time decisions in dynamic environments
Strong cross-functional collaboration and stakeholder communication skills
Qualification:
Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm)
Or a Science graduate with relevant industry experience
Competencies:
In-depth knowledge of shop floor operations for OSD and sterile formulations
Experience in handling and managing contract manufacturers
Strong understanding of GMP/GLP requirements
Strong problem-solving and decision-making abilities
Effective communication and coordination skills

📌 Assistant Manager - External Quality (Navi Mumbai)
🏢 Shalina Healthcare
📍 Navi Mumbai