Manufacturing- DP Packing- Assistant Manager
1 week ago
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics’ portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients’ worldwide.
Education : Bachelors/Masters degreeExperience : 8-10 YearsKey Skills - QMS, Deviation, Pharma Expereince
Primary Responsibilities
1. To perform the cleaning of the area and equipment's as per the respectiveprocedures and according to supervisor instructions.2. To perform the machine settings and to operate the machines as per theprocedure.3. To obtaining specimen certification for labels, cartons, etc. as perinstructions of supervisor / Batch record.4. To obtain the necessary equipment change part(s) from the supervisor beforestart of machine setting and return the change part post completion of thebatch/ product (as applicable).5. Execution batch packing activity for vials, cartridges, PFS and Pens fordomestic and export batches for both serialised and Non-Serialized productsas per the batch record instruction.6. For serialized products , perform the barcode verification on thelabels, cartons, shippers, pallets as per the batch record instructions.7. Arranging of product in storage areas (Cold rooms, Ambient room, Dryingroom) in presence of supervisor and to made the necessary entries respectivedocuments.8. Transfer of packing materials to respective packing line(s) from / to Daystorage area, vice versa.9. If any discrepancy reported / identified during cleaning and operation ofequipments / area, same to be informed to respective supervisor.10. Responsible to record the on-line entries in necessary logbooks / checklists /documents, etc as applicable.11. To get the issuance and handover of logbooks / checklists /documents from/to QA as applicable.12. To complete the assigned and necessary training/s as per the cGMPrequirement.13. Monitoring and assigning the tasks to associates according to the activitiesmentioned in the Batch records / respective procedures.14. Responsible for checking Cleaning of packing, inspection and CNC areas byvacuum cleaner and floor scrubber as per the requirement.15. Responsible for checking preparation of disinfect solution preparation.16. Responsible for checking cleaning of storage areas (Cold room / Ambientroom / Drying Room / Day Storage area).17. Responsible to follow the cGMP and GDP requirements as per therequirement.18. Responsible to follow the safety requirements as per EHS procedures.
Secondary Responsibilities
1. To ensure the cleanliness of the area and equipment are being performed byoperators / Associates as per the respective procedures.2. Assigning and monitoring the tasks to operators / associates according to theactivities mentioned in the Batch records / respective procedures.3. Raising request to warehouse for dispensing of secondary packing materialsas per BPR indent.4. Dispensed materials consumption and Excess unused materials return towarehouse.5. Obtaining line clearance certification for both area and equipment before startof the batch and post completion of the batch as per the procedure.6. Obtaining specimen certification for packing materials such as labels,cartons, etc… as per requirement.7. Execution of batch packing activity for vials, cartridges, PFS and Pens fordomestic and export batches for both serialised and Non-Serialized products.8. Loading and unloading of good vials, cartridges, PFS and Pens from B1, B2to W20 – Packing area.
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