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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.

 -Robust 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

 -Robust Communication Skills

 -Attention to Detail

 -Quality Consciousness

 -Problem Solving Ability

📌 Senior Officer Ankleshwar
🏢 DigiCAD
📍 Ankleshwar