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 on-site, 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