Position Profile : Candidate shall be overall responsible for administration & supervision of all day to day activities in Compression/ Coating/ Encapsulation department (Approx. 20 work centers) in a shift.
Responsibilities & duties
1. Adherence to follow and maintain quality systems and cGMP standards.
2. To ensure the compliance to Safety Standards in the department.
3. Responsible for execution of production activities in line with daily/weekly/monthly plan.
4. Responsible for Production output in shift and to improve the production efficiency.
5. Manpower handling, Manpower allocations and shift scheduling .
6. To ensure online completion and reviewing of all GMP documents in department.
7. Responsible for ensuring critical process parameters as per specification in order to achieve the good quality products produced.
8. To ensure the maintenance & cleanliness of facility & equipment.
9. To prepare, review, verify and implement departmental SOPs & train the workmen to follow the cGMP norms.
10. To review and ensure compliance, calibration, preventive maintenance of all machines/instruments in department.
11. Handling & troubleshooting related to the process/equipment in a shift.
12. To participate in execution of pre-exhibit, exhibit & process validation batches & cleaning validation activities.
13. Imparting training , development and to keep motivation at shop floor.
14. To co-ordinate with all inter departments (eg: QA, QC, STORE, Eng., PT & HR) for smooth running of production.
15. To handle the manufacturing related SAP transactions.
16. To participate actively during GMP/regulatory audits in department.
Qualification: B. Pharm / M. Pharm
Work experience & skills
Essential : 8-10 years of experience in Manufacturing
Desirable : Candidate with experience in large scale manufacturing activity in regulatory market environment USFDA , MHRA