Assistant Manager - External Quality

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 QualityBase location: Navi Mumbai (Mahape)Reporting to : Sr. Manager - QualityRole OverviewThe 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 regionAct as the regional quality representative for compliance and quality-related mattersPerform finished goods (FG) inspection, batch record review, and batch release activitiesReview finished product data to support new third-party product launchesEnsure in-process quality assurance (IPQA) across dosage forms including: Tablets and capsules (OSD), Oral liquids, External preparations & Sterile formulationsMonitor shop floor activities to ensure compliance with GMP standardsExecute and review process validation and stability studiesPrepare Annual Product Quality Reviews (APQR)Witness manufacturing processes and finished product analysisConduct quality audits of contract manufacturers and track compliance actionsManage relationships and coordination with CMOsPreferred Candidate:10–12 years of relevant experience in pharmaceutical quality operationsStrong exposure to GMP environments and regulatory inspectionsHands-on experience in shop floor quality operationsWillingness to travel extensively across India and internationallyAbility to make independent, real-time decisions in dynamic environmentsStrong cross-functional collaboration and stakeholder communication skillsQualification:Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm)Or a Science graduate with relevant industry experienceCompetencies:In-depth knowledge of shop floor operations for OSD and sterile formulationsExperience in handling and managing contract manufacturersStrong understanding of GMP/GLP requirementsStrong problem-solving and decision-making abilitiesEffective communication and coordination skills