Senior Officer

1. Perform the In process checks, ensure in-process

control, online process verification and its

documentation during the manufacturing and

packaging of batches.

2. Verify the line clearance activities in warehouse,

manufacturing and packing for all the batches.

3. Perform sampling during packaging of validation,

exhibit and commercial batches. Collect the in

process, Bulk, finished product, AQL, Hold time,

Reserve, freeze thaw, stability study, swab samples

along with documentation and sent to stakeholders.

4. Verify the Preventive maintenance, calibration,

Periodic Qualification and cleaning status of

manufacturing and Packaging equipment s.

5. Review of Executed BPRs prior to batch release

6. Review of Packing and Warehouse activity log

books.

7. Review of documents for Regulatory

submissions.

8. Maintenance and documentation of IPQA office

including temperature monitoring and cleaning of

the IPQA office.

9. Issuance of documents such as log book,

formats to the various departments.

10. Reducing the market complaints and product

recalls through effective in process control.

11. Access and use of IT Application i.e. MS office ,

outlook , team viewer , adobe acrobat reader ,

Genesis system, TMS and Usage of Aspire learning

management system etc.

12. Implementation and verification of cGMP,

quality systems and procedures in the

manufacturing, filling, Packing and warehouse.

13. Preparation of protocol and report for freeze

thaw study and monitoring of the product freeze

thaw studies.

14. Maintain Environment, Health and Safety

system as per ISO 14001:2015 ISO 45001:2018.

15. Any other tasks assigned by the supervisors..