Senior Officer Job in Cadila Pharmaceuticals Ltd at Ankleshwar

Principal Tasks & Responsibilities

 -Review and verify Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and other manufacturing documents for -
completeness and compliance.
 -Ensure manufacturing activities are performed as per approved SOPs, cGMP requirements, and regulatory guidelines.
 -Perform line clearance activities before commencement of manufacturing and packaging operations.
 -Review and approve production area and equipment cleaning status.
 -Monitor compliance of production activities through routine shop floor observations and quality checks.
 -Handle deviations, incidents, and non-conformances by performing investigation and ensuring timely CAPA implementation.
 Initiate and review Change Controls, CAPA, and Quality Risk Management activities.
 -Support process validation, cleaning validation, analytical method validation, and equipment qualification activities.
 -Ensure compliance with Data Integrity (ALCOA+) principles in documentation practices.
 -Review SOPs, protocols, reports, and quality documents as per applicable procedures.
 -Coordinate with Production, QC, Engineering, Warehouse, and EHS departments for quality-related activities.
 Participate in internal audits, customer audits, and regulatory inspections.
 -Track audit observations and ensure effective implementation of corrective and preventive actions.

Key Skills & Competencies

Functional / Technical:
 - Knowledge of Pharmaceutical Quality Assurance systems.
 -Strong understanding of cGMP, GDP, and regulatory requirements.
 -Knowledge of Batch Manufacturing Record (BMR) review and documentation practices.
 -Knowledge of deviations, CAPA, Change Control, and investigation processes.
 -Understanding of Process Validation and Cleaning Validation.
 -Knowledge of Qualification activities (DQ/IQ/OQ/PQ).
 -Knowledge of Data Integrity requirements.
Behavioural:
 - Teamwork and Collaboration
 -Strong Communication Skills
 -Attention to Detail
 -Quality Consciousness
 -Problem Solving Ability