Officer - Pharmaceutical Production Compliance

Role Summary

This role involves ensuring strict adherence to current Good Manufacturing Practices (cGMP), Good Practice (GxP), and Environmental Health & Safety (EH&S) standards within a pharmaceutical production setting. The position requires thorough participation in training, compliance with Standard Operating Procedures (SOPs), and proactive reporting of any deviations, quality concerns, or improvement opportunities.

Key Responsibilities

• Oversee daily allocation and planning of departmental tasks to meet market demands and commitments.
• Monitor production stages including IMS, blister, strip, bulk, powder, and batch splitting activities.
• Ensure correct labeling on shippers as per EMO and conduct SAP transactions for finished products.
• Manage product packing and documentation following Batch Packing Records (BPR), SOPs, and cGMP guidelines.
• Coordinate movement of bulk materials, packing materials, semi-finished, and finished goods in line with SOPs.
• Track and update Overall Equipment Efficiency (OEE) regularly.
• Maintain cleanliness of production area and machinery according to GMP requirements.
• Operate, wash, and clean relevant equipment as per SOP instructions.
• Conduct in-process quality checks as specified in BPRs and document results.
• Monitor environmental parameters such as differential pressure, temperature, and humidity as required by SOP.
• Ensure equipment calibration and preventive maintenance are performed on schedule to standards.
• Manage initiation and review of requests including material requisitions, returns, and packing material carry-forward.
• Document area and equipment usage accurately following SOPs.
• Handle procurement, issuance, and disposal of change parts for packing.
• Perform online reconciliation and review of batch packing records.
• Contribute to preparation and review of SOPs, batch packing records, process validations, and equipment qualifications.
• Lead on-job training sessions for employees and contractual workers in the department.
• Manage change controls, deviations, and Corrective and Preventive Actions (CAPA) through the Quality Assurance Management System (QAMS).
• Investigate market complaints, deviations, and non-conformances; implement corrective/preventive measures within set timelines.
• Coordinate with Production Planning & Control (PPC), Production Maintenance, Engineering, and Quality Control departments to ensure smooth operations.
• Adhere to personal hygiene and organizational rules before entering production areas.
• Plan dispensing activities in collaboration with production planning to ensure timely availability of packing materials.
• Manage effective utilization of manpower, machinery, and materials while maintaining inventory of operational supplies.
• Support the Quality Management System by reporting any discrepancies, abnormalities, non-conformances, or incidents to departmental leadership.
• Verify labels, inserts/outserts with batch packing records and ensure retention of all necessary packing material proofs.
• Troubleshoot and validate software systems including barcode scanning (1D and 2D), ACG inspection systems for labels, blister inspection, inkjet coding, Data Acquisition System (DAS), and Caliber QAMS.
• Perform additional responsibilities as delegated by the department head.

Candidate Profile

Candidates should possess 2 to 5 years of relevant experience, with a graduation degree in Pharmacy. Key competencies for this role include strong collaboration skills, customer focus, talent development, innovative and creative thinking, process excellence orientation, results-driven mindset, stakeholder management abilities, and strategic agility.