Manufacturing- DP Packing- Assistant Manager

1 month ago

bangalore, India Biocon Biologics Full time

About the Company

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 degree

Experience: 8-10 Years

Key Skills- QMS, Deviation, Pharma Expereince

Primary Responsibilities

1. To perform the cleaning of the area and equipment's as per the respective

procedures and according to supervisor instructions.

2. To perform the machine settings and to operate the machines as per the

procedure.

3. To obtaining specimen certification for labels, cartons, etc. as per

instructions of supervisor / Batch record.

4. To obtain the necessary equipment change part(s) from the supervisor before

start of machine setting and return the change part post completion of the

batch/ product (as applicable).

5. Execution batch packing activity for vials, cartridges, PFS and Pens for

domestic and export batches for both serialised and Non-Serialized products

as per the batch record instruction.

6. For serialized products , perform the barcode verification on the

labels, cartons, shippers, pallets as per the batch record instructions.

7. Arranging of product in storage areas (Cold rooms, Ambient room, Drying

room) in presence of supervisor and to made the necessary entries respective

documents.

8. Transfer of packing materials to respective packing line(s) from / to Day

storage area, vice versa.

9. If any discrepancy reported / identified during cleaning and operation of

equipments / 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 cGMP

requirement.

13. Monitoring and assigning the tasks to associates according to the activities

mentioned in the Batch records / respective procedures.

14. Responsible for checking Cleaning of packing, inspection and CNC areas by

vacuum 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 / Ambient

room / Drying Room / Day Storage area).

17. Responsible to follow the cGMP and GDP requirements as per the

requirement.

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 by

operators / Associates as per the respective procedures.

2. Assigning and monitoring the tasks to operators / associates according to the

activities mentioned in the Batch records / respective procedures.

3. Raising request to warehouse for dispensing of secondary packing materials

as per BPR indent.

4. Dispensed materials consumption and Excess unused materials return to

warehouse.

5. Obtaining line clearance certification for both area and equipment before start

of 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 for

domestic and export batches for both serialised and Non-Serialized products.

8. Loading and unloading of good vials, cartridges, PFS and Pens from B1, B2

to W20 – Packing area.

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