Job Description

Department Details

Role Summary

1. Responsible to get trained on quality and safety procedures. Good manufacturing practices at workplace, adherence to Standard Operating Procedures and updating of production and quality documents.
2. To follow the established procedures and policies of the company pertaining to quality systems and Environment Health and Safety.
3. Responsible for QMS documentation, audit preparedness and process compliance verification.
4. Handling Change Management, deviations (process related), OOS (Out of Specification), OOT (Out of Trend) and CAPA management up to the closures related to PDS Manufacturing.
5. Regular visit to PDS manufacturing to support Continuous Process Verification and identifying the areas for improvement.
6. Support manufacturing operational trouble shooting and root cause analysis.
Data trending and monitoring for routine manufacturing batches.
7. Responsible to Prepare Master Formula Record (new product) / Process Validation / Cleaning Validation and Hold Time Study protocols and reports as per the manufacturing needs. Monitoring the activity during execution.
8. Responsible for preparation of risk assessment / study protocols & reports as per the manufacturing needs.
9. To engage with internal and external stakeholders for execution of New project/modification activities at PDS
10. Preparation and review of qualification documents for the New projects and modification activity
11. To perform facility fit assessment for the new product introduction and process changes.
12. Identify the constraints and debottlenecking of the manufacturing section by identifying the potential bottlenecks.
13. To apply appropriate Commissioning and Qualification strategy for any assigned project and define the list of activities required
14. Review and follow-up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirements
15. To support continuous process and quality improvements in PDS.
16. To support production operation for investigation of equipment related deviations.
17. To comply with EHS policies and procedures.
18. To standardize and improve process efficiency for upstream and downstream - design engineering support for manufacturing scale-up and implementation.
19. To work across organizational for gathering technical and quality inputs related to projects and production operations.

20. To monitor the compliance with the requirements of Good Manufacturing Practice
21. To ensure the instructions relating to production operations are strictly followed
22. To perform and document operations in accordance with Cgmp
23. To comply with EHS policies and procedures
24. To ensure that all production deviations, CAPA, OOS, OOT for DSP-2 operation are reported, evaluated and investigated.
25. To ensure deviations, CAPA, OOS, OOT are closure as per timelines
26. To ensure the CAPA implementation and effectiveness
27. Preparation of SOP, EOP and Checklist, Log Sheets and related document
28. To ensure training is completed for all the activities related to DSP-2 operation.
29. Training of all the employees and ensure the training records are updated.
30. Archival of documents in the archival room and ensure the completeness of tracking in the document receipt log.
31. Audit Compliance - Coordinating with auditor during internal and external audits, prepare compliance report and propose CAPA for audit findings. Ensure CAPA are effectively carried out initiating appropriate CAPA reports.
32. Responsible for routine review and checking of SOP and EOP. Maintaining controlled copies and display copies as applicable of all documents, records and log books issued to the department.

Key Responsibilities

1. Responsible to get trained on quality and safety procedures. Good manufacturing practices at workplace, adherence to Standard Operating Procedures and updating of production and quality documents.
2. To follow the established procedures and policies of the company pertaining to quality systems and Environment Health and Safety.
3. Responsible for QMS documentation, audit preparedness and process compliance verification.
4. Handling Change Management, deviations (process related), OOS (Out of Specification), OOT (Out of Trend) and CAPA management up to the closures related to PDS Manufacturing.
5. Regular visit to PDS manufacturing to support Continuous Process Verification and identifying the areas for improvement.
6. Support manufacturing operational trouble shooting and root cause analysis.
Data trending and monitoring for routine manufacturing batches.
7. Responsible to Prepare Master Formula Record (new product) / Process Validation / Cleaning Validation and Hold Time Study protocols and reports as per the manufacturing needs. Monitoring the activity during execution.
8. Responsible for preparation of risk assessment / study protocols & reports as per the manufacturing needs.
9. To engage with internal and external stakeholders for execution of New project/modification activities at PDS
10. Preparation and review of qualification documents for the New projects and modification activity
11. To perform facility fit assessment for the new product introduction and process changes.
12. Identify the constraints and debottlenecking of the manufacturing section by identifying the potential bottlenecks.
13. To apply appropriate Commissioning and Qualification strategy for any assigned project and define the list of activities required
14. Review and follow-up technical documentation from the early design phase in order to ensure alignment with GMP and CQV requirements
15. To support continuous process and quality improvements in PDS.
16. To support production operation for investigation of equipment related deviations.
17. To comply with EHS policies and procedures.
18. To standardize and improve process efficiency for upstream and downstream - design engineering support for manufacturing scale-up and implementation.
19. To work across organizational for gathering technical and quality inputs related to projects and production operations.

20. To monitor the compliance with the requirements of Good Manufacturing Practice
21. To ensure the instructions relating to production operations are strictly followed
22. To perform and document operations in accordance with Cgmp
23. To comply with EHS policies and procedures
24. To ensure that all production deviations, CAPA, OOS, OOT for DSP-2 operation are reported, evaluated and investigated.
25. To ensure deviations, CAPA, OOS, OOT are closure as per timelines
26. To ensure the CAPA implementation and effectiveness
27. Preparation of SOP, EOP and Checklist, Log Sheets and related document
28. To ensure training is completed for all the activities related to DSP-2 operation.
29. Training of all the employees and ensure the training records are updated.
30. Archival of documents in the archival room and ensure the completeness of tracking in the document receipt log.
31. Audit Compliance - Coordinating with auditor during internal and external audits, prepare compliance report and propose CAPA for audit findings. Ensure CAPA are effectively carried out initiating appropriate CAPA reports.
32. Responsible for routine review and checking of SOP and EOP. Maintaining controlled copies and display copies as applicable of all documents, records and log books issued to the department.

Educational Qualifications

Required Education Qualification: MA/ M.Com / M.Sc
Required Experience: 6 - 8 years

Biocon