Description
JOB DESCRIPTION
This role is responsible for executing manufacturing and packaging operations within a regulated pharmaceutical environment, ensuring products are packed accurately, efficiently, and in compliance with cGMP and global regulatory requirements. The role oversees packaging lines including CVC lines, blister lines, bottle filling, labeling, and track & trace systems while ensuring operational readiness, productivity, and data integrity. The incumbent leads production officers and operators, manages batch documentation, master records, validations, equipment qualifications, ERP transactions, and training programs. It coordinates with internal functions and external vendors to ensure timely execution of commercial, validation, and stability batches. The role drives continuous improvement, compliance, deviation management, and overall departmental performance aligned with quality, safety, and delivery goals.
Essential Functions
- Supervise and execute manufacturing and packaging activities on CVC lines, blister lines, bottle filling, labeling, and track & trace systems
- Guide, coordinate, allocate work, and lead production officers and operators to achieve production, quality, and delivery targets
- Prepare, review, and implement SOPs, formats, Master Batch Manufacturing Records (MBMR), and Master Batch Packaging Records (MBPR)
- Execute and review commercial, process validation, stability, and qualification batches as per approved protocols
- Prepare, review, and implement URS, qualification protocols, performance qualification records, and equipment qualification activities
- Ensure accurate batch documentation, final BPR review, ERP work order completion, shipment confirmation, OEE data entry, and production reporting
- Manage deviations, change controls, investigations, and CAPA related to manufacturing and packaging operations
- Coordinate with QA, QC, Stores, Purchase, HR, Engineering, Maintenance, and external vendors for timely batch execution and issue resolution
- Conduct training on SOPs, GDP, OJT modules, and update training records in systems such as AIMS
- Maintain department compliance with cGMP norms, housekeeping, calibration schedules, track & trace CSV updates, and continuous improvement initiatives
Additional Responsibilities
QUALIFICATIONS
Education
- B. Pharm - Required
- Master Degree (MS/MA) M. Sc. - Preferred
Experience
- 2 years or more in 2 - 5 Years
