Job Description

Department Details
Role Summary
Primary Responsibilities:
1. Responsible for all qualification and validation activities of facility, equipment and at site 2 Drug substance facilities (includes B1,B3,B4,B5,QC-Q8,QC-Q17,QC-Q19,QC-Q19B,W20 and W21).
2. Review and approval of documents related to Commissioning and Qualification (URS to PQ/RQ), SOPs for equipment / utility operation and Engineering SOP's, as applicable.
3. Preparation and review of Standard Operating Procedures relevant to qualification & validations and to impart training (Including General Training relevant to the team).
4. Monitoring of commissioning and qualifications (FAT/SAT/IQ/OQ/IOQ/PQ/RQ) of equipment, facility, and utilities at site 2 Drug substance facilities.
5. Review and approval of periodic re-qualification planner and regular follow-ups for performing the qualifications within the due date.
6. Review and approval of Calibration, Preventive Maintenance planner and ensuring the calibration and preventive maintenance activities done as per planner.
7. Review of QMS documents like Change Controls, Deviations and Risk Assessment related to Equipment / Utility and facility, as applicable.
8. Support during investigations and to suggest / review CAPA related to facility, utility, and equipment, as applicable.
9. Review and approval of facility, utility, and equipment layouts.
10. Preparation / Review and approval of FRP.
11. Shopfloor inspection / QA on shopfloor to check compliance (engineering relevant aspects) to cGMP / cGEP at regular intervals.
12. Support (relevant to engineering and maintenance aspects) during regulatory and customer audits.
13. Issuance and control of qualification related protocols and documents, as applicable.
14. Support all the activities that are taken to enhance the facility and systems, as per regulatory requirements.
15. Educate/training to cross functional teams on quality requirements, operating procedures relevant to Engineering QA aspects.
16. Ensure safe work practices are followed at workplace.
17. Follow GDP while preparation, review, and approval of documents.
18. Adhere to the Data Integrity Policy of Biocon.
19. Timely completion of assigned trainings in LMS (as per revision and annual refresher training planner)
20. Ensuring cGMP requirements while performing and reviewing of qualifications & validations.
Secondary Responsibilities:
1. Support continuous improvement initiatives identified within Engineering QA functions.
2. Technical support for site engineering and maintenance teams, as required.
3. Contribute for harmonization of SOPs across multiple Biocon sites.
4. Provide a backup support for routine activities, in case of emergency.
5. Any other responsibility assigned by Head QA / Designee.
Key Responsibilities
Primary Responsibilities:
1. Responsible for all qualification and validation activities of facility, equipment and at site 2 Drug substance facilities (includes B1,B3,B4,B5,QC-Q8,QC-Q17,QC-Q19,QC-Q19B,W20 and W21).
2. Review and approval of documents related to Commissioning and Qualification (URS to PQ/RQ), SOPs for equipment / utility operation and Engineering SOP's, as applicable.
3. Preparation and review of Standard Operating Procedures relevant to qualification & validations and to impart training (Including General Training relevant to the team).
4. Monitoring of commissioning and qualifications (FAT/SAT/IQ/OQ/IOQ/PQ/RQ) of equipment, facility, and utilities at site 2 Drug substance facilities.
5. Review and approval of periodic re-qualification planner and regular follow-ups for performing the qualifications within the due date.
6. Review and approval of Calibration, Preventive Maintenance planner and ensuring the calibration and preventive maintenance activities done as per planner.
7. Review of QMS documents like Change Controls, Deviations and Risk Assessment related to Equipment / Utility and facility, as applicable.
8. Support during investigations and to suggest / review CAPA related to facility, utility, and equipment, as applicable.
9. Review and approval of facility, utility, and equipment layouts.
10. Preparation / Review and approval of FRP.
11. Shopfloor inspection / QA on shopfloor to check compliance (engineering relevant aspects) to cGMP / cGEP at regular intervals.
12. Support (relevant to engineering and maintenance aspects) during regulatory and customer audits.
13. Issuance and control of qualification related protocols and documents, as applicable.
14. Support all the activities that are taken to enhance the facility and systems, as per regulatory requirements.
15. Educate/training to cross functional teams on quality requirements, operating procedures relevant to Engineering QA aspects.
16. Ensure safe work practices are followed at workplace.
17. Follow GDP while preparation, review, and approval of documents.
18. Adhere to the Data Integrity Policy of Biocon.
19. Timely completion of assigned trainings in LMS (as per revision and annual refresher training planner)
20. Ensuring cGMP requirements while performing and reviewing of qualifications & validations.
Secondary Responsibilities:
1. Support continuous improvement initiatives identified within Engineering QA functions.
2. Technical support for site engineering and maintenance teams, as required.
3. Contribute for harmonization of SOPs across multiple Biocon sites.
4. Provide a backup support for routine activities, in case of emergency.
5. Any other responsibility assigned by Head QA / Designee.
Educational Qualifications
Required Education Qualification: Msc
Required Experience: 3 - 5 years