Executive

Rubicon Research Limited; Thane; On-site; INR 1,100,000 - 1,500,000; Full time

Job summary

Rubicon Research Limited in Thane, Mumbai, is seeking an Executive to join Corporate Quality Assurance to lead vendor qualification, risk assessment, and ongoing monitoring of API, excipient, packaging material, service, and CMO vendors.

You will support regulatory inspections, manage quality systems, documentation, change controls, and qualification reports, drawing on your 6–8 years of experience in GMP-compliant supplier management.

Qualifications

• Bachelor of Pharmacy or Master of Science required.
• 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.

Responsibilities

• Lead qualification, approval, periodic requalification, and risk assessment of API, excipient, packaging, laboratory and service providers vendors.
• Monitor vendor performance through complaints, OOS/OOT, changes, CAPA trends, audit history, and supply-related quality events; support regulatory inspections/audits.
• Strong working knowledge of US FDA 21 CFR 210/211, EU GMP/EudraLex Volume 4, ICH Q7/Q9/Q10, PIC/S and WHO GMP requirements; apply regulatory expectations to supplier qualifications and risk management.
• Manage vendor-related Quality Agreements, change controls, deviations, investigations, CAPA, and periodic reviews; maintain inspection-ready qualification documentation and database.

Skills

Vendor qualification experience

Regulatory guidance knowledge

SAP/ERP exposure

QMS exposure

Vendor management systems

Excel/Power BI dashboards

Education

Bachelor of Pharmacy

Master of Science

Tools

SAP

ERP

Excel

Power BI

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.

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

• Strong 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.