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

Robust 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 qualificat

📌 Executive (Thane)
🏢 Rubicon Research
📍 Thane