Job Description:

Purpose:
Responsible for qualification, evaluation, monitoring, and periodic requalification of API, excipient, packaging material, service, and CMO vendors in compliance with GMP, regulatory, and company requirements.
Position / Job Title:
Sr. Officer
Department:
Corporate Quality Assurance (CQA)
Reporting To:
Sr. Manager CQA
Location:
Thane, Mumbai
Years of Experience:
3 – 5 years
Dosage Form:
All applicable dosage forms (Oral solid, Nasal, Liquid oral, Topical, Injectable)

Job Responsibilities / Deliverables:
Vendor & CMO Qualification / Requalification:
Execute day-to-day qualification and periodic requalification of API, excipient, packaging material, laboratory, service providers,
Review vendor questionnaires, GMP certificates, licenses, regulatory approvals, audit reports, and quality documentation
Maintain vendor qualification status and ensure activities are completed within defined timelines
Support vendor onboarding and qualification of recent suppliers in coordination with Procurement and other functions





Supplier Audits & Performance Monitoring:
Coordinate and support in office, remote, and desktop vendor audits
Support periodic vendor performance reviews and escalation of significant quality concerns.

Regulatory & GMP Compliance:
Working knowledge of US FDA 21 CFR Parts 210/211, EU GMP/EudraLex Volume 4, ICH Q7, Q9 and Q10, with familiarity with PIC/S and WHO GMP
Assess supplier documentation against applicable GMP and regulatory requirements

Quality Systems & Documentation:
Support preparation and maintenance of Quality Agreements with vendors
Evaluate vendor change notifications and support impact assessment through the change control process
Maintain accurate and current vendor qualification records, databases, trackers, and supporting documentation

Cross-Functional Coordination & Continuous Improvement:
Coordinate with Procurement, QC, Manufacturing, Regulatory Affairs, Supply Chain and R&D; teams for timely

📌 Senior Officer Thane
🏢 Rubicon Research
📍 Thane