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. Role & responsibilities
- 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 profile
- 1012 years of relevant experience in pharmaceutical quality operations
- Strong 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 energetic 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

📌 Associate Manager (Navi Mumbai)
🏢 Shalina Healthcare
📍 Navi Mumbai