Sr. Officer / Executive- VQ (CQA)

Rubicon Research; Thane; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Rubicon Research is seeking a professional to lead vendor qualification and risk assessment for APIs, excipients, packaging, labs and services. You will review regulatory documentation and ensure compliance across global inspections.

The role drives documentation, change controls and supplier governance while supporting audits at Rubicon sites. The candidate should have pharma education and experience with SAP/ERP, Excel or Power BI-based dashboards, and willingness to travel across Rubicon

Qualifications

• Lead qualification, approval, requalification and risk assessment of API, excipient, packaging, lab and service providers.
• Review GMP certificates, licenses, inspection history, technical docs and compliance records.
• Exposure to SAP/ERP and dashboards is preferred.

Responsibilities

• Monitor vendor performance through complaints, CAPA trends, audit history and quality events.
• Support regulatory inspections and responses for supplier oversight.
• Prepare qualification reports, risk assessments, audit reports, and maintain inspection-ready docs.
• Drive improvements in vendor qualification processes and governance.

Skills

Vendor qualification

Risk assessment

Quality systems

Regulatory compliance

Audit support

Education

Bachelor of Pharmacy

Master of Science

Tools

SAP/ERP

Excel

Power BI

Job description

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.