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
Robust 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
Solid 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 External Quality Shalina Laboratories Pvt Navi Mumbai (India)
🏢 Shalina Healthcare
📍 India