1. Bench work related to lab development of various APIs and intermediates (Starting from literature search to commercialization).
2 . Synthetic/Synthesis/Chemical research
3. To record and maintain online experimental details and analytical results.
4. Validation and commercialize the Lab Developed Products.
5. To maintain and ensure good housekeeping and safety.
6. To supervise the activities of Chemists.
7. To prepare and maintain GMP and GLP in the Lab.
QA
1. Internal Audits / self-inspections / un-announced audits including necessary CAPA tracking.
2. Support during the regulatory / external customer / contract laboratory audits.
3. RA supporting activities in case of DMF filings etc.
4. Marketing supporting activities in case of market complaints / recalls / returns etc.
5. Handling of hold time studies / stability studies individually.
6. Handling of the retention samples.
7. Preparation & review of Annual Product Review.
8. Review of process development reports / master BPCRs / validation protocols / reports etc.
9. Analytical data review like Specifications & Standard testing Procedures. Analytical method
validation Protocol, report & concerned documents.
10. Review of Analytical data of all Raw materials, In-process & Intermediate with continuous
monitoring for both QC & Microbial related samples& trending of Data.
11. Product releases / labelling / sealing and relevant documentation activities.
12. Vendor qualification activities.
13. Managing data archiving & retrieving procedures.
14. Preparation of audit compliance reports and subsequent follow ups to implement CAPAs.
15. Line clearance activities.
16. Other QMS relevant activities like change controls / deviations / OOS & OOT etc.,
17. Expertize in computer operations (excel / word / PPT / mails etc.)
18. Review of Master Production Control Record based on Technology Transfer Dossier or Product
Development Report.
19. Filling of Customer Questionnaires and arrange related documents.
20. Awareness on validations (process / cleaning).
21. Awareness on ICH Q7 guidelines
Venue:
22 Dec from 10 AM
Contact: Anu Verma
Saurav Chemicals Limited
Bhagwanpura Unit-3,Barwala Road,
Derabassi,Chandigarh ambala Highway.
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