Role & responsibilities:

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

Preferred candidate profile:

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

Interested Candidates can apply or directly share on [email protected]

📌 Sr. Officer / Executive- VQ (CQA) (Thane)
🏢 Rubicon Research
📍 Thane