15h Left : Assistant Production Manager

Department : Production ( Injectable )

Designation : Assistant Manager

Experience : 7 to 10 Years

Location : Bavla, Ahmedabad

Education : M. Pharma, B. Pharma, M. Sc

Job Description :

1. To Follow the growing procedure during and exit in clean room, manufacturing and in autoclave area.

2. To Follow the personal hygienic and clean room behavior in the production area.

3. To responsible For All type of activity performed in dispensing and manufacturing area.

4. Before dispensing reverification of calculation of API and ensure same to be reverified by IPQA.

5. To Ensure the dispensing Of API and Excipients is as per respective BMR and Related SOPs.

6. To reverify the dispensed API before Start of Manufacturing Operation.

7. To Check and performed the CIP and SIP of Manufacturing tank to use for Manufacturing and holding of batch.

8. To check the calibration and qualification status of tank before start of manufacturing.

9. To take the line clearance form IPQA Before start of manufacturing operation.

10. To Complete of documents Of Ongoing operations in Dispensing and Manufacturing Area.

11. To Inform to Production Manager for Dispensing and Manufacturing related activities.

12. To ensure the area monitoring, cleaning & Sanitization of all classified and non- classified area, temperature & %RH Monitoring in all production area.

13. To Follow the clean room behavior in aseptic area and to train the people who area working in classified area about aseptic area behavior and aseptic practice.

14. To perform dispensing and manufacturing of products as per procedure mentioned in BMR.

15. To operate the Manufacturing vessel in manufacturing area as per defined procedure.

16. To inform the Production Manager for breakdowns if any and to intimate the engineering department through defined procedure for breakdowns if any.

17. Ensure to send the wash water during product change or batch change as per defined in SOP.

18. To check and control all critical parameters during batch manufacturing.

19. To make entry in Pharma Cloud software as per production activity. To intimate the IPQA personnel to collect and send. the bulk sample to QC at the end of batch manufacturing.

20. To do online documentation in logbooks and BMR.

21. To prepare and review of SOP of Production area as per regulatory and CGMP requirements.

22. Prepare and revised the BMR for new and existing products.

23. To co-ordinate with dispensing area personnel for the dispensing of raw materials.

24. To co-ordinate with filling area personnel for their filtration of product solutions.

25. To intimate QC department for bulk testing of product in advance.

26. To co-ordinate with QC department for bulk testing.

27. To co-ordinate with QA department for line clearance related activity, Qualification, Validation and Media fill related activity.

28. To co-ordinate with engineering department for routine maintenance and preventive maintenance related activity.

29. To implement continuous improvement for all production activity as suggested.

30. To participate in execution of qualification and validation activity in accordance with QA and Engineering department.

31. To give awareness and SOPs training to the the personnel working in Dispensing and manufacturing area

32. To prepare requisition slip for outside maintenance 'work of machine or machine parts.

33. Do all other work given by management as and when required. Ensure to always follows the safety norms of plant.

• Transportation and Canteen Facility Available.

Regards,

Pruthviraj Mandora

6352978952

E- mail : - Recruitment@swiss.in

URL : - www.swiss.in