1.Responsible for compounding, Filling, Sealing activities of Manufacturing Line.
2.To verify/ensure the Indenting and issuance of Raw materials, Primary packaging materials as per the production plan through ERP.
3.Receipt, Transfer and Return of Raw materials required for Batch production.
4.Monitoring of environmental conditions like Temperature, Differential Pressures and Relative Humidity as per SOP.
5.Monitoring of Cleaning and Sanitization of the areas as per SOP.
6.Coordination with validation team during qualification and requalification of equipment/area.
7.To Ensure Prior intimation to validation team regarding any qualification, requalification of area, equipment and facility.
8.To Ensure the Process flow, Personnel flow; Material flow shall be done as per the pre-defined procedures.
9.Preparation and review of SOPs, and review of Batch records and process related protocols.
10.To perform/ensure the cleaning of items, equipment’s and machine parts as per the SOP.
11.Information to Immediate Supervisor in case any anomalies found in the machine/area.
12.Close monitoring of the completion of batch Compounding.
13.Batch Planning and man power management as per the requirement.
14.To ensure the on line completion of batch records and log books and completion of batch transactions through ERP.
15.Maintaining minimum inventory of clean room consumables, items and spares of equipment’s.
16. Follow the fogging procedure as per SOP.
17. Compounding and Filtration of Bulk solution as per SOP.
18.CIP / SIP of Transfer lines, compounding vessels as per SOP.
19.Operation of Filter Integrity Testing Machine.
20.Integrity testing of Hydrophilic and Hydrophobic filters as per SOP.
21.Initiation, review and timely closure of all QMS elements like Change control, PNC, Exceptions and CAPA as per procedure.
22.Attending trainings like on job, cGMP, External and Giving training on process related SOP?s.
23.Updating cGMP related practices and recent regulatory up gradation to the personnel working in the shop floor to improve the systems.
24.Co-ordination with training team and ensures the completion of training of all the production personnel working in respective areas.
25.Following safety systems and GMP systems during the work execution.
26.To perform air flow visualization study (smoke study) as per approved protocol/sop.
27.Any other job assigned by Reporting Head.
Qualification : B. Pharma/M. Pharma
Total Experience : 4-8 Years
Must have exposure of Regulatory Audits