Sr. Officer / Executive- VQ (CQA)

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:

• 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

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 removed]