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Senior Officer

Cadilapharma · cadilapharma.com
AnkleshwarSenior
Apply on Cadilapharma’s site

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The job in short

Senior officer.

AuditWarehouse

Details

Found
26 d ago · posted 2026-09-21
Location as listed
Ankleshwar, India
Role
Specialist / Analyst (other)
Source
The company’s own careers site

Full description

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

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