The Officer/Executive – Production will be responsible for overseeing day-to-day manufacturing and packing activities, ensuring compliance with SOPs, monitoring in-process controls, and maintaining accurate documentation. The involves coordination with cross-functional teams, handling QMS activities, supporting production planning, and driving continuous improvement in productivity, quality, and compliance across the shop floor.
Roles and Responsibilities:
- Monitor and execute line clearance of area and equipment as per SOP checklists during manufacturing and packing stages.
- Ensure proper in-process control activities as per batch records and SOP requirements across all production stages.
- Maintain and monitor strict adherence to cGMP practices on the shop floor to ensure regulatory compliance.
- Verify environmental conditions such as temperature, relative humidity, and differential pressure records regularly.
- Review operational, cleaning, and equipment usage records to ensure compliance with procedures.
- Verify preventive maintenance records of equipment and ensure timely completion of maintenance activities.
- Compile and review batch manufacturing and packing records before submission to QA for final approval.
- Handle QMS activities including deviation management, investigation preparation, and CAPA implementation.
- Initiate and manage change controls, deviations, predictive maintenance, and breakdown memos as required.
- Prepare and update Standard Operating Procedures (SOPs) in line with current practices and regulatory requirements.
- Manage documentation activities such as rejection forms, additional material requests, and breakdown reports.
- Perform SAP-related activities including process order release, requisition generation, test requests, material reconciliation, and bonding slip generation.
- Handle registration samples by planning, checking stock availability, and coordinating packing activities.
- Maintain and update training records, including Training Needentification (TNI) and SOP training summaries.
- Monitor preventive and breakdown maintenance activities to ensure minimal downtime and efficient operations.
- Track and control productivity parameters such as rejection, wastage, relabeling, repacking, and yield optimization.
- Ensure proper storage, calibration, and verification of standard weights and weighing balances as per SOP.
- Participate in and handle self-inspection and internal audits for the production department.
- Prepare and execute monthly and weekly production planning in alignment with PPMC requirements.
- Oversee daily compliance activities and ensure all shop-floor operations meet regulatory and internal standards.
- Train and guide junior staff and operators to ensure adherence to SOPs and best practices.
- Participate in quality-related training programs, webinars, and continuous learning initiatives.
- Coordinate with QA, QC, Engineering, and Warehouse teams for smooth production operations.
- Drive continuous improvement initiatives to enhance productivity, efficiency, and compliance.
- Ensure proper housekeeping, safety practices, and discipline across the production area.
- Perform any additional responsibilities assigned by the Head of Department from time to time.