Designation: Senior Executive / Junior Manager
Experience: 04 to 09 years
Education: B Pharm \ M Pharm
Department: Development Quality Assurance - Formulation Department.
Roles & Responsibilities
1. Issuing of Batch Manufacturing Records, Analytical Raw data's and maintaining the respective log books.
2. Issuing of registers and formats for all departments and maintaining of records for issuance and reconciliation.
3. Issuance approval, Issuance and Retrieval of the documents in eDMS.
4. Receiving, Issuing and reviewing the bio batches related executed Batch Manufacturing Records, Analytical raw data's and archiving.
5. Responsible for review of product development documents and analytical documents related to technology transfer.
6. Preparation and review of departmental SOPs
7. Reviewing of Equipment qualification protocols and Reports.
8. Review of supplier qualification documents.
9. Review of calibration documents
10. Receiving and reviewing of executed raw data's & ATRs and archiving for bio batches.
11. Reviewing of analytical method validation protocols & reports.
12. Maintenance, Retrieval and Archiving of all GMP related documents and records.
13. Preparation & review of department Schedules
14. Responsible for document distribution to the user departments.
15. Responsible for Document control activities.
16. Responsible for preparation, review and submitting License Applications.
17. Handling of Change controls (Permanent and Temporary), OOS and Incidents.
18. Responsible for approval of documents in absence of Head - FDQA.
19. Responsible for performing job assigned by Head
FDQA or his authorized designee.
Interested and relevant candidate share updated profiles along with current CTC, expected CTC and notice period.
Please apply only if your profile is matching the above requirements to narasimharaju.manthena@msnlabs.com
