ASSISTANT MANAGER
- Malaysia
- Permanent
- Full-time
1. Responsible for all the manufacturing 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 and approval related to qualification of Equipment's/utilities/system and new qualification/ projects (green field/brown field)
2. Review and approval 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 control, production, Warehouse and engineering and maintenance for harmonization across site.
4. Monitoring & verification of validation activities for equipment's and facility as per planned and approved protocols.
5. Review and approval of Calibration checklist 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 of at site 2 facilities (includes B1, B2, 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 provide comments for the same.
11. Review and approval of deviations 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 documents
16. Adhere to the Data Integrity Policy of BioconKey ResponsibilitiesJob Roles and Responsibilities:
1. Responsible for all the manufacturing 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 and approval related to qualification of Equipment's/utilities/system and new qualification/ projects (green field/brown field)
2. Review and approval 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 control, production, Warehouse and engineering and maintenance for harmonization across site.
4. Monitoring & verification of validation activities for equipment's and facility as per planned and approved protocols.
5. Review and approval of Calibration checklist 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 of at site 2 facilities (includes B1, B2, 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 provide comments for the same.
11. Review and approval of deviations 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 documents
16. Adhere to the Data Integrity Policy of BioconEducational QualificationsRequired Education Qualification: M.Sc
Required Experience: 5 - 8 years