Job Description

Department DetailsRole Summary1. Responsible for all the manufacturing at site of Drug substance and Drug product facilities. Review and approval related to qualification of Equipments/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. Shopfloor inspection / QA on shopfloor to check compliance (Qualification relevant aspects) to cGMP / cGEP at regular intervals.
6. Review and approval of functional specifications / design documents and should have good knowledge of process automation.
7. All DCS Application design review based on programming standards and design guidelines
8. Detail process philosophy designing review and approval of the systems -CIP/SIP Skids, Fermenters, Process Vessels, Temperature Control Units, Biokill/Decontamination System, Complete Integrated Skid for Pharmaceutical and Biopharmaceutical Industries as per ASME BPE and GMP standard.
9. CIP, SIP, Process (Fully Auto Process, Batch Designing, Semi-Auto Process) philosophy finalization review and approval.
10. Review and approval of PFD, P&ID, FS, FDS, Valve matrix, Phases, Sequences, EM, CM for Process Equipments as per ISA88 Standard.
11. Testing of Process equipments in various stages of Simulation/Bench Test, FAT, SAT, IOQ & Site support. Synching with the current GAMP, GDP, ISA-88 guidelines. Performing & Verification of Process.
12. Equipments verification, IO testing, 21 CFR check, Access level checks.
13. Review and approval of system architectures, hardware and software design documents.

• 14. Good understanding of Process Automation, System Architecture, ISA S88 Batch, pharma process, good engineering practice, GDP & regulatory knowledge would be preferable.
• 15. Hands on experience on Delta V, PCS 7 Siemens and ABB applications.

Key Responsibilities1. Responsible for all the manufacturing at site of Drug substance and Drug product facilities. Review and approval related to qualification of Equipments/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. Shopfloor inspection / QA on shopfloor to check compliance (Qualification relevant aspects) to cGMP / cGEP at regular intervals.
6. Review and approval of functional specifications / design documents and should have good knowledge of process automation.
7. All DCS Application design review based on programming standards and design guidelines
8. Detail process philosophy designing review and approval of the systems -CIP/SIP Skids, Fermenters, Process Vessels, Temperature Control Units, Biokill/Decontamination System, Complete Integrated Skid for Pharmaceutical and Biopharmaceutical Industries as per ASME BPE and GMP standard.
9. CIP, SIP, Process (Fully Auto Process, Batch Designing, Semi-Auto Process) philosophy finalization review and approval.
10. Review and approval of PFD, P&ID, FS, FDS, Valve matrix, Phases, Sequences, EM, CM for Process Equipments as per ISA88 Standard.
11. Testing of Process equipments in various stages of Simulation/Bench Test, FAT, SAT, IOQ & Site support. Synching with the current GAMP, GDP, ISA-88 guidelines. Performing & Verification of Process.
12. Equipments verification, IO testing, 21 CFR check, Access level checks.
13. Review and approval of system architectures, hardware and software design documents.

• 14. Good understanding of Process Automation, System Architecture, ISA S88 Batch, pharma process, good engineering practice, GDP & regulatory knowledge would be preferable.
• 15. Hands on experience on Delta V, PCS 7 Siemens and ABB applications.

Educational QualificationsRequired Education Qualification: Msc
Required Experience: 6 - 9 years

Biocon