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 current 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 completion of vendor qualification activities
- Identify opportunities to improve vendor qualification procedures, templates, risk assessment tools, and tracking systems.

Qualifications &

- Pre-Requisites

- Bachelor of Pharmacy / Master of Science
- Experience in vendor qualification activities and knowledge of international regulatory guidance. Exposure to SAP/ERP, electronic QMS, vendor management systems preferred

Additional Notes It would require travelling across Rubicon sites during various regulatory / customer audits at manufacturing sites.

📌 Senior Officer (Thane)
🏢 Rubicon Research
📍 Thane