Senior Executive

Shop-Floor QA / GMP Compliance
Perform routine QA oversight of API manufacturing and packaging operations.
Ensure manufacturing activities are performed according to approved SOPs, BMR/BPR, specifications, and GMP requirements.
Conduct line clearance and area/equipment verification before commencement of manufacturing activities.
Monitor critical manufacturing activities and ensure compliance with approved process parameters.
Verify equipment status, cleaning status, calibration status, and area conditions.
Ensure proper identification and status labeling of raw materials, intermediates, solvents, finished products, and equipment.
Raise and document GMP observations and ensure timely corrective actions.
2. Batch Documentation & Review
Review Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), equipment logbooks, and associated GMP documents.
Ensure entries are complete, accurate, traceable, and contemporaneous.
Review manufacturing yields, reconciliation, process parameters, IPC results, and deviations.
Ensure batch documentation is completed and reviewed within the defined timelines.
Support batch disposition/release activities in coordination with QA management.
3. Deviation, Investigation & CAPA
Initiate, review, and support investigation of deviations, incidents, OOS/OOT, process failures, and market complaints, as applicable.
Participate in root-cause analysis using appropriate investigation tools.
Prepare and monitor CAPA plans and verify effectiveness.
Ensure investigations are scientifically sound, properly documented, and completed within timelines.
4. Change Control
Review and assess change controls related to manufacturing processes, equipment, facilities, materials, analytical methods, documents, and utilities.
Coordinate with Production, QC, Engineering, Regulatory Affairs, and other functions for impact assessment.
Monitor implementation of approved changes and ensure required documentation is completed.
5. SOP & Quality System
Prepare, review, and revise SOPs, specifications, formats, protocols, and other quality documents.
Ensure implementation of the site Quality Management System.
Support periodic review of SOPs and controlled documents.
Ensure training is completed before implementation of new or revised procedures.
6. Audit & Inspection Readiness
Support internal audits, customer audits, regulatory inspections, and GMP audits.
Prepare documents and records required for audits and inspections.
Track audit observations and support timely implementation and closure of commitments.
Maintain the assigned areas in an inspection-ready condition.
7. Training & Compliance
Provide GMP and quality-system training to Production, QC, Warehouse, Engineering, and other relevant personnel.
Monitor compliance with data integrity and good documentation practices.
Promote a strong quality culture throughout the manufacturing area.
8. Cross-Functional Coordination
Coordinate with Production, QC, Warehouse, Engineering, EHS, and Regulatory Affairs to resolve quality-related issues.
Provide QA guidance during manufacturing process deviations and abnormal events.
Support continuous improvement and risk-reduction initiatives.
Required Knowledge
Strong knowledge of ICH Q7, GMP, GDP, data integrity, and API manufacturing requirements.
Knowledge of BMR/BPR review and shop-floor QA activities.
Good understanding of deviations, CAPA, change control, OOS/OOT, investigations, and risk assessment.
Familiarity with regulatory expectations for API manufacturing.
Understanding of documentation practices and traceability requirements.
Key Skills
GMP and regulatory compliance
Batch record review
Deviation investigation
CAPA and change control
Root-cause analysis
Audit/inspection handling
Documentation and data integrity
Problem-solving and decision-making
Cross-functional coordination
Team leadership and communication
Key Performance Indicators (KPIs)
Timely and accurate batch record review
GMP compliance and reduction in recurring observations
Timely closure of deviations, CAPA, and change controls
Audit/inspection readiness and compliance
Effectiveness of investigations and CAPA
Training compliance
Data integrity and documentation compliance
Reduction in repeat deviations and quality incidents