OFFICER / EXECUTIVE QUALITY ASSURANCE (VENDOR QUALIFICATION)

Department: Quality Assurance – Corporate Quality Assurance

Position: Officer / Executive – QA (Vendor Qualification)

Reporting To: AGM – Corporate Quality Assurance

Location: Head Office

Number of Positions: 01

Industry: Pharmaceutical – Finished Formulations

1. JOB PURPOSE

To manage and coordinate the Vendor Qualification and Vendor Quality Management System for vendors/suppliers of APIs, excipients, packaging materials, contract service providers and other quality-critical materials/services, ensuring compliance with applicable GMP, regulatory requirements and company SOPs. The incumbent will be responsible for vendor evaluation, qualification, documentation, periodic requalification, quality audits, CAPA follow-up and maintenance of approved vendor records.

1. KEY RESPONSIBILITIES

A. Vendor Qualification & Evaluation
- Coordinate the complete Vendor Qualification process from initial evaluation through approval and periodic requalification.
- Review and evaluate vendor qualification documents, questionnaires and supporting records.
- Coordinate collection and review of:

- GMP certificates

- Manufacturing/Business licenses

- ISO certificates

- Product specifications

- COA formats
- DMF/technical documents, wherever applicable

- TSE/BSE declarations
- Non-GMO declarations
- Allergen/Gluten-free declarations

- Nitrosamine statements

- Elemental impurity declarations

- Residual solvent declarations

- Regulatory approvals/certificates
- Quality manuals and other relevant quality documents.
- Evaluate vendor compliance against approved qualification criteria and SOP requirements.
- Prepare/review Vendor Qualification Reports (VQR) and recommend qualification status to the concerned authority.
- Maintain and update the Approved Vendor List (AVL) under the direction of CQA.

B. Vendor Audit Management
- Coordinate on-site, remote and desktop vendor audits as per approved audit plans.
- Prepare audit schedules, agendas and audit-related documentation.
- Participate in vendor audits as a QA representative, wherever required.
- Prepare/coordinate audit reports and communicate observations to vendors.
- Follow up with vendors for timely submission of CAPA plans and supporting evidence.
- Review CAPA responses for adequacy and effectiveness under the guidance of AGM – CQA.
- Maintain vendor audit records and track closure of audit observations.

C. Vendor Requalification & Periodic Review
- Monitor vendor qualification validity and initiate periodic vendor requalification within defined timelines.
- Conduct periodic review of vendor performance, quality history and regulatory status.
- Review complaints, deviations, rejected batches, OOS/OOT trends and other quality-related issues associated with vendors.
- Recommend continuation, requalification, suspension or disqualification of vendors based on documented evaluation and Management/CQA decision.
- Maintain vendor requalification trackers and ensure timely completion.

D. Quality Agreements
- Coordinate preparation, review and execution of Quality/Technical Agreements with qualified vendors, where applicable.
- Ensure quality responsibilities, change notification requirements,



deviation handling, complaint management, documentation and regulatory responsibilities are appropriately defined.
- Maintain records of executed Quality Agreements and monitor their validity/review status.

E. Vendor Performance Monitoring
- Coordinate periodic assessment of vendor performance based on defined quality parameters.

- Monitor

- Material quality

- COA compliance

- Rejection/retest trends

- Complaints
- OOS/OOT, where applicable

- Deviations

- Delivery/quality performance

- Change notifications

- Audit observations
- Regulatory/GMP status.
- Prepare vendor performance evaluation reports and escalate significant concerns to AGM – CQA.

F. Change Control & Regulatory/GMP Monitoring
- Review vendor change notifications and coordinate assessment of their impact on product/material quality.
- Maintain records of changes notified by vendors.
- Coordinate with QA, QC, Regulatory Affairs, Purchase and other concerned departments for appropriate evaluation and implementation.
- Monitor expiry/validity of critical vendor certificates and regulatory documents.
- Escalate significant GMP/regulatory changes or compliance concerns to AGM – CQA.

G. Documentation & Data Management
- Maintain complete and controlled Vendor Qualification Files (VQF).
- Maintain electronic and physical records of vendor-related documents.

- Maintain trackers for

- New vendor qualification

- Vendor requalification

- Vendor audits

- CAPA closure

- Quality Agreements

- Certificate validity

- Vendor performance
- Change notifications.
- Ensure documents are properly indexed, traceable and readily retrievable during audits/inspections.
- Prepare periodic MIS reports for Management/CQA.

1. CROSS-FUNCTIONAL COORDINATION

Coordinate with:
- Purchase / Procurement
- QA / QC
- Production
- Warehouse
- Regulatory Affairs
- R&D; / Technical
- Supply Chain
- Approved vendors and service providers
- External auditors/consultants, wherever applicable.

The incumbent shall ensure that vendor-related quality activities are completed within approved timelines and in accordance with applicable procedures.
1. REGULATORY & GMP RESPONSIBILITIES

- Ensure Vendor Qualification activities comply with applicable GMP requirements, regulatory expectations and company SOPs.
- Support preparation of vendor-related documentation for customer audits, regulatory inspections and internal audits.
- Assist in responding to audit/inspection observations related to vendor qualification and supplier management.
- Keep updated with applicable GMP expectations related to supplier qualification and quality risk management.

1. EDUCATIONAL QUALIFICATION

Essential:

- B.Pharm / M.Pharm / Pharm.D or equivalent pharmaceutical qualification.

Preferred:

- M.Pharm / PG Diploma in Quality Assurance / Regulatory Affairs or equivalent.

1. EXPERIENCE

Officer:



Minimum 2–3 years relevant experience in Pharmaceutical QA, Vendor Qualification, Supplier Quality or Quality Systems. Executive: Minimum 3–5 years relevant experience in Pharmaceutical QA, Vendor Qualification, Supplier Quality or Quality Systems.

Experience in API, excipient, Packaging material and Testing service-provider qualification will be preferred.

1. REQUIRED KNOWLEDGE & SKILLS

- Good knowledge of pharmaceutical GMP and Quality Management Systems.
- Practical knowledge of Vendor Qualification and Supplier Quality Management.
- Knowledge of vendor audits and CAPA evaluation.
- Understanding of Quality Agreements and change notification requirements.
- Good documentation and report-writing skills.
- Working knowledge of MS Word, MS Excel and PowerPoint.
- Good analytical and evaluation skills.
- Strong follow-up and coordination capability.
- Good written and verbal communication skills.
- Ability to review technical and quality documents critically.
- High attention to detail and accuracy.

1. DESIRABLE KNOWLEDGE

Knowledge/exposure to:
- WHO-GMP
- EU-GMP
- ICH Guidelines
- ICH Q9 – Quality Risk Management
- ICH Q10 – Pharmaceutical Quality System
- Supplier/Vendor Quality Management
- GDP principles
- Data Integrity
- Audit management
- CAPA
- Change Control
- Deviation Management
- OOS/OOT
- Pharmaceutical Quality Risk Assessment.

1. KEY PERFORMANCE INDICATORS (KPIs)

- Timely completion of new vendor qualification.
- Timely completion of periodic vendor requalification.
- Timely closure of vendor audit observations/CAPA.
- Accuracy and completeness of Vendor Qualification Files.
- Timely execution and renewal of Quality Agreements.
- Timely review of vendor change notifications.
- Effective vendor performance monitoring.
- Compliance with applicable SOPs and GMP requirements.
- Audit/inspection readiness of vendor qualification documentation.

1. PERSONAL ATTRIBUTES

- Strong quality mindset and professional integrity.
- Excellent documentation and organizational skills.
- Good communication and vendor coordination abilities.
- Robust follow-up and ownership.
- Analytical approach with attention to detail.
- Ability to work independently and meet defined timelines.
- Willingness to travel for vendor audits, where required.
- Ability to maintain strict confidentiality of company and vendor information.

1. AUTHORITY & ESCALATION

The incumbent shall perform Vendor Qualification activities within the authority delegated by the AGM – Corporate Quality Assurance. The employee shall not independently approve, suspend, disqualify or reinstate a vendor unless such authority is formally delegated. Significant quality, GMP, regulatory or compliance concerns shall be immediately escalated to the AGM – CQA.

1. GENERAL

The above responsibilities are indicative and not exhaustive. Management may assign additional responsibilities related to Corporate Quality Assurance, Vendor Qualification, Supplier Quality Management, Quality Systems, audits and GMP compliance based on organizational requirements. The employee shall comply with all applicable company policies, SOPs, GMP requirements, quality systems and instructions issued by Management

📌 Walk-in || Officer / Executive - CQA (Navi Mumbai)
🏢 PSA Chemicals And Pharmaceuticals
📍 Navi Mumbai