Role Objective:

The primary objective of this role is to manage and oversee Quality Management System (QMS) documentation, audits, and compliance activities at a corporate level. The incumbent will ensure that all manufacturing sites and contract testing laboratories (CTLs) adhere to established protocols, regulatory requirements, and internal SOPs to maintain the highest standards of product quality

KEY RESPONSIBILITIES

- QMS & Document Control: Perform comprehensive reviews of QMS documents, including change controls, APQR, SOPs, OOS/OOT investigations, Deviations, CAPA, and Validation Master Plans.

- Audit & Compliance: Participate in surprise audits, self-audits of corporate functions, and assigned vendor audits as per the annual schedule.

- Contract Testing Laboratory (CTL) Management: Handle Quality Agreements, review site-specific test lists, schedule audits, and perform proactive yearly assessments of CTLs.

- Manufacturing Site Support: Coordinate LIMS-related activities and provide in office support for document reviews and investigations at Nerul, Daman, Vadodara, and Baddi sites.

- Change Management: Review change assessments related to manufacturing sites and corporate functions, ensuring follow-up with Cross-Functional Teams (CFT) for action completion.

- Customer & Regulatory Interaction: Manage customer questionnaires, respond to regulatory queries, and handle the logging and investigation of customer complaints in TrackWise Digital (TWD).

- Project Implementation: Support the implementation of new digital projects, such as TrackWise Digital,



and initiate Global CAPA assessments.

- Risk Management: Conduct risk-based qualification of Raw Material (RM) and Packaging Material (PM) vendors.

STAKEHOLDER INTERACTION

Type of Interaction: Internal

Interaction with: Cross-Functional Teams (CFT), Manufacturing Site Heads, Supply Chain, and Corporate Functions.

Nature of Interaction: Coordination for change assessments, follow-ups on action items, providing SOP training, and collaborating with supply chain for complaint sample retrieval.

Type of Interaction: Internal & External

Interaction with: Contract Testing Laboratories (CTLs), Customers, Regulatory Agencies, and Vendors

Nature of Interaction: Negotiating and renewing Quality Agreements, responding to technical queries/audits, and performing risk-based vendor qualifications

JOB REQUIREMENTS

Professional Experience and Relevant Skills

- Experience: 10- 15 years of experience in QMS document review, Audit & Compliance, and Standard Analytical Procedures within the Pharmaceutical industry.

- Technical Skills:

- Experience with LIMS, TrackWise Digital (TWD), and SAP.

- Deep understanding of APQR, CAPA, OOS/OOT, and Site Master File (SMF) requirements

- Soft Skills: Expertise in handling Recall/Mock Recall procedures and Global CAPA assessments

Academic Qualifications & Certifications

- Educational Qualification: B. Pharm / M. Pharm or M.Sc. in Chemistry/Analytical Chemistry.

- Area of Expertise: QMS document review, Audit & Compliance, and Standard Analytical Procedures

📌 Assistant Manager - CQA (India)
🏢 USV
📍 India