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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.

 -Solid 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)
🏢 DigiCAD
📍 Ankleshwar