Zydus Cadila : Hiring for PRODUCTION QMS/PREPARATION BMR BPR - Apply Now

 

Zydus Cadila : Hiring for PRODUCTION QMS/PREPARATION BMR BPR - Apply Now

Job Description 

1. Preparation and revision of SOPs of production department as per respective procedures.
2. Handling of quality management system (QMS) i.e. Change control , deviation, CAPA and risk assessment of production department as per respective SOPs.
3. Preparation and revision of batch records of drug product and media fill.
4. Preparation of presentation as suggested by department head/manager.
5. Preparation of qualification documents like  IQ, OQ, PQ of equipment/instruments/machines, PQ of area and compilation of data after execution of data after execution.
6. Preparation of URS (user requirements specification) of equipment/instrument and machine.
7. Review of technology transfer document(TTD) of all new drug product batches.
8. Review of executed batch records of all drug products, aseptic process simulation studies and other studies(if any).
9. Review of all document of all drug product are like attachments/annexure of SOPs and forms like breakdown, deviation, change control, etc. in  line of GDCP and regulatory requirements.
10. To supervise Visual inspection activity in all product batches, aseptic process simulation studies and other studies.
11. To supervise routine activity like area Cleaning & Sanitization, Temperature monitoring, Humidity monitoring, Differential pressure monitoring and Scheduled activity like Non-viable particle count monitoring as per respective SOP's.
12. To supervise qualification activities in Visual inspection area along with their documentation.
13. To supervise cleaning, operation, validation, calibration and maintenance activities of machines and equipment's/ instrument's along with their documentation.
14. Review, recording and documentation of batch manufacturing records; attachment's/ annexure's of related SOP's and other related document's by following Good documentation control practices and regulatory requirements.
15. To prepare and implement SOP's for operation and cleaning of machine/ area/ system of Visual inspection area and to participate in trainings related to the Visual inspection activity and cGMP. 
16. Handling of training activities and preparation of training relevant documents.
17. In case of no Visual inspection activities, will also be responsible for supervision of Vial Decartoning area, External vial washing area and General production area along with their documentation.

Interested one kindly share CV at Shreya.Nambiar@zyduscadila.com