Job Description

Department DetailsRole Summary1. Preparation, Execution & Compilation of PQ, RQ documents for Process Equipments as per cGMP compliance. 2. Revision of approved qualification (i.e., PQ/RQ/Study protocol & Report/Technical Document) document, whenever required. 3. Responsible to complete assigned activities as per the defined timelines. 4. Equipment qualification, technical documents, Risk assessment and study documents preparation and activity execution. 5. Handling and Operation of Data loggers/Wireless sensors for Qualification execution. 6. To co-ordinate with the CFT for achieving the day-to-day validation targets. 7. Maintenance of all Validation and qualification documents related to B1 and B2 Fill finish. 8. Assistance to teammate during validation of all the equipment\'s present within the production area like the Autoclave, Cold Room, Filling Machines, Sealing Machines, Tunnel, Deep freezer and all new equipment and instruments, automatic vial/cartridge washing machine etc. 9. Report incidents or any deviations immediately to the superiors. 10. Providing training to CFT for the prepared documents. 11. Identification, initiation and closer of discrepancy and change control related to validation activity in eVLMS. 12. Review of CFT SOP\'s comparing with validation documents. 13. Responsible for reporting any kind of illness or any abnormal health condition to immediate supervisors so that appropriate action can be taken. 14. Adherence to safety, health, hygiene, and environmental measures. 15. To strictly adhere to the standard operating procedures and good documentation practice.Key Responsibilities1. Preparation, Execution & Compilation of PQ, RQ documents for Process Equipments as per cGMP compliance. 2. Revision of approved qualification (i.e., PQ/RQ/Study protocol & Report/Technical Document) document, whenever required. 3. Responsible to complete assigned activities as per the defined timelines. 4. Equipment qualification, technical documents, Risk assessment and study documents preparation and activity execution. 5. Handling and Operation of Data loggers/Wireless sensors for Qualification execution. 6. To co-ordinate with the CFT for achieving the day-to-day validation targets. 7. Maintenance of all Validation and qualification documents related to B1 and B2 Fill finish. 8. Assistance to teammate during validation of all the equipment\'s present within the production area like the Autoclave, Cold Room, Filling Machines, Sealing Machines, Tunnel, Deep freezer and all new equipment and instruments, automatic vial/cartridge washing machine etc. 9. Report incidents or any deviations immediately to the superiors. 10. Providing training to CFT for the prepared documents. 11. Identification, initiation and closer of discrepancy and change control related to validation activity in eVLMS. 12. Review of CFT SOP\'s comparing with validation documents. 13. Responsible for reporting any kind of illness or any abnormal health condition to immediate supervisors so that appropriate action can be taken. 14. Adherence to safety, health, hygiene, and environmental measures. 15. To strictly adhere to the standard operating procedures and good documentation practice.Educational QualificationsRequired Education Qualification: B.Tech
Required Experience: 5 - 7 years

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