Senior Officer Job in Cadila Pharmaceuticals Ltd at Ankleshwar

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 Good 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