Group Leader

Job Description

Purpose of the role: This position will form an integral part in achieving all quality objectives by developing & implementing the current Quality procedures and systems in line with global regulatory expectations and industry practices. Need to work closely with all CFT team in a collaborative manner to build a Quality system. Primary Responsibility: 1. Lead all personnel and processes involved in Inspection and Packaging operations occurring on all shifts. 2. Maintain knowledge of state-of-the-art Biopharmaceutical industry standards and guidelines for inspection and packaging concepts, practices, and processes. 3. Responsible for DP facility packing activities (operation and cleaning of Visual inspection board, Plunger rod insertion & Labelling machine, Cartridge Labelling machine, Blister packing machine, Automatic Cartoning Machine, Pen Assembling and labelling machine, Cold room) related to drug product. 4. Assist the installation and commissioning activities like FAT, SAT etc. of the packing lines for Vials, PFS and Cartridge facility packing. 5. Preparation and review of the URS, QRM, IQ, OQ and PQ protocols for Plunger rod insertion & Labelling machine, Cartridge Labelling machine, Blister packing machine, Automatic Cartoning Machine, weighing balances, Pen Assembling and labelling machine, Serialization etc. 6. Ensure QMS compliance in qualification, visual inspection and packing related activities. 7. Assist the validations of equipment and the process. 8. Identify and implement the visual inspection and packing procedures with compliance to current GMP requirements. 9. Implementation of Track & Trace system for the packaging. 10.Performing the FAT & SAT of packing line equipment at vendor sites or at our facility. 11. Performing/executing the IQ, OQ and PQ related to packaging lines. 12. Performing the visual inspection activities. 13. Assisting the validation activities of other equipment like cold room, pass-box and area. 14. Prepare & review of all SOP`s/protocols related to visual inspection/packing area procedures/equipment and drug product facility. 15. Identify and implement the manufacture procedures with compliance to current GMP requirements. 16. Timely initiation, investigation, impact assessment of QMS elements.