Senior Officer

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 new 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.