Principal Tasks & Responsibilities Execute API manufacturing activities as per approved Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs). 
- Execute Quality Assurance activities as per approved SOPs, cGMP requirements, and regulatory guidelines.  -Review and verify Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and other quality documents for completeness and compliance.  -Perform line clearance activities for manufacturing and packaging operations.  -Monitor manufacturing activities through shop floor quality oversight and ensure adherence to approved procedures.  -Review and approve production-related documents, logbooks, and records as per defined procedures.  -Ensure proper implementation of Valuable Documentation Practices (GDP) and Data Integrity (ALCOA+) principles.  -Initiate, review, and support investigation of deviations, incidents, and non-conformances.  -Support preparation and implementation of CAPA, Change Control, and Quality Risk Management activities.  -Support Process Validation, Cleaning Validation, Equipment Qualification, and technology transfer activities.  -Review SOPs, protocols, validation reports, and other controlled documents.  -Coordinate with Production, QC, and Warehouse, Engineering, and EHS departments for quality-related activities.  -Participate in internal audits, customer audits,



and regulatory inspections.  -Ensure timely closure of audit observations and CAPA actions.  -Support Product Quality Review (PQR/APQR), trending activities, and quality monitoring programs.  -Provide guidance and support to junior QA team members for effective execution of activities.  -Identify compliance gaps and support continuous improvement initiatives. Key Skills & Competencies Functional / Technical: 
- Good knowledge of Pharmaceutical Quality Assurance systems.  -Strong understanding of cGMP, GDP, and regulatory compliance requirements.  -Knowledge of API manufacturing processes and quality requirements.  -Experience in Batch Manufacturing Record (BMR) review.  -Knowledge of deviations, CAPA, Change Control, and investigation procedures.  -Understanding of Process Validation and Cleaning Validation.  -Knowledge of Equipment Qualification (DQ/IQ/OQ/PQ).  -Knowledge of Data Integrity requirements.  -Experience in audit preparation and compliance activities.  -SAP/ERP and MS Office knowledge.  -Good documentation and review skills. Behavioural:  -Teamwork and Collaboration  -Strong Communication Skills  -Leadership Ability  -Attention to Detail  -Problem Solving Skills  -Decision Making Ability  -Result Orientation  -Time Management

📌 Senior Officer (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar