We seek an experienced Quality Assurance Manager to enhance our Quality Assurance and Compliance function and support our expanding clinical trial supply operations in India and Bulgaria.

Location: Pune, India | On-site | Depot-based

Role Scope: India and Bulgaria

Department: Quality Assurance and Compliance

Reports to: Head of Quality Assurance

What We’re Looking For

We are seeking a quality professional with proven hands-on expertise in:

· Clinical Trial Supplies & Depot Quality Operations

· Quality Management Systems (QMS / eQMS)

· Computer System Validation (CSV)

· GxP, cGMP, and cGDP compliance

· FDA 21 CFR Part 11, EU Annex 11, and Annex 13

· Cold-chain and temperature-controlled logistics

· Data integrity and computerized system compliance

· Regulatory, sponsor, and vendor audits

· Deviation, CAPA, and change control management

· Quality Risk Management (QRM)

Experience

· At least 5 years of QA experience in the pharmaceutical, biotech, CRO, or CDMO sector

· At least 2 years of direct experience in a clinical trial supplies depot workplace, including exposure to global distribution networks

· Hands-on experience with eQMS platforms such as Veeva Vault, TrackWise, MasterControl, or similar systems

· Practical experience in CSV within a GxP-regulated environments





Key responsibilities include:

· Managing and strengthening QMS and global and local compliance frameworks

· Driving eQMS, CSV, data integrity, and computerized system compliance

· Supporting regulatory inspections and global sponsor audits

· Overseeing quality aspects of clinical supply receipt, storage, release, quarantine, and distribution

· Ensuring quality oversight of cold-chain, ultra-low, and ambient storage operations

· Reviewing clinical supply, packaging, labeling, and cross-border shipping documentation

· Leading vendor qualification, audits, and Quality Risk Management

· Supporting harmonized quality practices across operations in India and Bulgaria

Qualification

Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Computer Science, or a related scientific or technical discipline.

What Will Help You Succeed

Strong technical writing, cross-cultural communication, stakeholder management, problem-solving, and collaboration skills, with the ability to work effectively with global teams, sponsors, and vendors.

Apply Now and Make a Global Quality Impact!

? Drop your CV here

? Or email your application to [email protected]

📌 Quality Assurance Manager (Clinical Trial Supplies) (Pune)
🏢 Quantime World
📍 Pune