DQA - Manager - Formulation

Role & responsibilities

1. SOP establishment, implementation of system process, note books, work books, protocols for testing and continuous monitoring of Quality Systems in R & D and ADL of Titan Laboratories and Titan Pharma Plus at various locations through SOPs and periodic inspections.

2. Documentation review , approval , Issuance, archival and control of all documents in R&D and ADL of Titan Laboratories and Titan Pharma Plus at various locations . Example Review and approval of MFR against the lab note books , specifications , MOA against analytical method validations , review of analytical method validation protocol and report. Review of ADL results against raw data. Calibration procedures and records of all equipment and instruments . Review of reference standards / working standards/impurities

3. Online review of R&D and ADL activities, daily in-process checks at RND+ADL , line clearances, all system similar to mfg.

4. ADL stability , method validation ,OOS, OOT , in process checks, method verification etc,

5. Review of documents for application of test licenses / manufacturing licenses of Titan Laboratories and Titan Pharma Plus

6. Review of PDR and all documents of R&D and ADL required for submission to regulatory authorities for Dossier registration for Titan Laboratories and Titan Pharma Plus

7. Establishment, implementation and continuous monitoring of Systems in various departments through SOP and periodic inspections

8. Timely escalations of issues impacting the development / testing of product

9. Support to all sites for audit preparations

10. Execution of any tasks assigned by Management from time to time basis