1. Job Purpose

To support Development Quality Assurance activities for CSBU-R&D; by ensuring compliance with applicable GMP, quality systems, regulatory requirements, and internal procedures across pharmaceutical development activities. The role involves review, monitoring, documentation, deviation management, and quality oversight of R&D; processes to ensure products are developed in accordance with defined quality standards.

2. Key Responsibilities

A. Quality Assurance & Compliance

* Ensure compliance with applicable GMP, GLP, regulatory guidelines, and internal quality systems.
* Provide QA oversight for pharmaceutical development activities and associated documentation.
* Review and approve/recommend approval of R&D; documents as per defined procedures and authorization matrix.
* Ensure adherence to SOPs, policies, specifications, protocols, and established quality standards.
* Support implementation and continuous improvement of quality systems within CSBU-R&D.;
B. Documentation & Data Review

* Review development protocols, reports, specifications, analytical documents,



batch records, and other quality-related documents.
* Ensure documentation is complete, accurate, traceable, and compliant with ALCOA+ principles.
* Review laboratory and development data for completeness and integrity.
* Maintain appropriate quality records and ensure timely closure of documentation activities.

C. Deviation, CAPA & Change Control

* Support investigation and review of deviations, incidents, OOS/OOT and other quality events.
* Participate in root-cause analysis and evaluation of CAPA effectiveness.
* Review and monitor change controls impacting R&D; activities.
* Ensure timely implementation and closure of assigned CAPA and quality actions.

D. Audits & Inspection Readiness

* Support internal audits, self-inspections, customer audits, and regulatory inspections.
* Coordinate with R&D; stakeholders to ensure timely closure of audit observations.
* Monitor compliance gaps and sup

📌 Senior Executive (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka