MANAGER
- Malaysia
- Tetap
- Sepenuh masa
2. Preparation & Review of protocols and reports for qualification/validation for facility and equipment in quality control, production, utility, engineering and Warehouse.
3. Review and approval of equipment/instrument related SOPs of quality assurance, quality control, production, Warehouse and engineering and maintenance.
4. Monitoring & verification of validation activities for equipment's and facility as per planned and approved protocols.
5. Review and approval of calibration procedure, checklist/ certificates and planners.
6. Review and approval of RQ procedure and planners.
7. Ensuring cGMP requirements while performing qualifications & validations.
8. Failure investigation, data analysis and Risk/Impact assessments for commissioning/ qualification /validations.
9. Support for regulatory audits and compliance related to qualification activities offsite 2 Drug substance and Drug product facilities (includes B1, B3, B4, B5, QC-Q8, QC-Q17, QC-Q19, QC-Q19B, W20 and W21).
10. Review of all change controls and related documents as per regulatory requirement and provide comments for the same.
11. Review and approval of deviation investigations.
12. Shopfloor inspection / QA on shopfloor to check compliance (Qualification relevant aspects) to cGMP / cGEP at regular intervals.
13. Educate/training to cross functional teams on quality requirements, operating procedures relevant to Qualification QA aspects.
14. Ensure safe work practices are followed at workplace.
15. Follow GDP while preparation, review, and approval of documents.
Adhere to the Data Integrity Policy of Biocon.
16. Secondary responsibilities (Wherever applicable):
Support Engineering & maintenance/Production in various activities for documentation as per requirementKey Responsibilities1. Responsible for all the manufacturing at at site 1,2 Drug substance and Drug product facilities (includes B1, B2, B3, B4, B5, QC-Q8, QC-Q17, QC-Q19, QC-Q19B, W20 and W21) Review related to qualification of Equipment's/utilities/system and new qualification/projects (green field/brown field)
2. Preparation & Review of protocols and reports for qualification/validation for facility and equipment in quality control, production, utility, engineering and Warehouse.
3. Review and approval of equipment/instrument related SOPs of quality assurance, quality control, production, Warehouse and engineering and maintenance.
4. Monitoring & verification of validation activities for equipment's and facility as per planned and approved protocols.
5. Review and approval of calibration procedure, checklist/ certificates and planners.
6. Review and approval of RQ procedure and planners.
7. Ensuring cGMP requirements while performing qualifications & validations.
8. Failure investigation, data analysis and Risk/Impact assessments for commissioning/ qualification /validations.
9. Support for regulatory audits and compliance related to qualification activities offsite 2 Drug substance and Drug product facilities (includes B1, B3, B4, B5, QC-Q8, QC-Q17, QC-Q19, QC-Q19B, W20 and W21).
10. Review of all change controls and related documents as per regulatory requirement and provide comments for the same.
11. Review and approval of deviation investigations.
12. Shopfloor inspection / QA on shopfloor to check compliance (Qualification relevant aspects) to cGMP / cGEP at regular intervals.
13. Educate/training to cross functional teams on quality requirements, operating procedures relevant to Qualification QA aspects.
14. Ensure safe work practices are followed at workplace.
15. Follow GDP while preparation, review, and approval of documents.
Adhere to the Data Integrity Policy of Biocon.
16. Secondary responsibilities (Wherever applicable):
Support Engineering & maintenance/Production in various activities for documentation as per requirementEducational QualificationsRequired Education Qualification: M.Sc
Required Experience: 12 - 16 years