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

Executive

Department

Corporate Quality Assurance (CQA)

Reporting To

Sr. Manager CQA

Location:

Thane, Mumbai

Years Of Experience

6 – 8 years

Dosage Form

All applicable dosage forms (Oral solid, Nasal, Liquid oral, Topical, Injectable)

Job Responsibilities / Deliverables

Vendor Qualification & Risk Assessment:

- Lead qualification, approval, periodic requalification, and risk assessment of API, excipient, packaging, laboratory and service providers vendors
- Evaluate vendor criticality and determine appropriate qualification and oversight requirements
- Review vendor questionnaires, GMP certificates, licenses, regulatory inspection history, technical documents, quality systems, and compliance records

Ongoing Performance Management

- Monitor vendor performance through complaints, OOS/OOT, changes, CAPA trends, audit history, and supply-related quality events.
- Support FDA, MHRA, EU, and other regulatory inspections/audits of Rubicon sites, including retrieval and presentation of supplier qualification evidence

Regulatory & GMP Compliance

- Solid working knowledge of US FDA 21 CFR 210/211,



EU GMP/EudraLex Volume 4, ICH Q7, Q9 and Q10, PIC/S and WHO GMP requirements
- Apply regulatory expectations to supplier qualifications, outsourced activities, quality agreements, risk management, and regulatory inspection readiness
- Support regulatory inspections and responses related to supplier/CMO oversight

Quality Systems, Documentation & Change Management

- Manage vendor-related Quality Agreements, change controls, deviations, complaints, investigations, CAPA, and periodic reviews
- Prepare and review qualification reports, risk assessments, audit reports, approval recommendations, and maintain inspection-ready documentation and qualification database.
- Drive improvements in vendor qualification processes, templates, risk models, and governance systems.
- Maintain complete, accurate, and inspection-ready vendor qualification documentation and electronic databases

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, or Excel/Power BI-based dashboards

Additional Notes

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

📌 Executive (Thane)
🏢 Rubicon Research
📍 Thane