Manager-Process Lead

1. Comprehensive understanding of scale-up, technology absorption, product transfer, process optimization, product robustness, and process performance qualification operations.

2. Expertize to detect gaps in the manufacturing process, potential for process improvements/optimization, and ability to lead the team to ensure resolution of technical issues in manufacturing, as well as to guarantee an adequate degree of process capability and process control for all products.

3. To have hands on experience of Manufacturing Operation of OSD/Semisolid/Respiratory formulations and related equipment.

4. Expertize in new product launches and commercialization.

5. Design and review protocols for scale-up and optimization, exhibit, pre-validation, process performance qualification, hold time studies, and investigation studies.

6. Create and review gap analysis reports, risk assessment reports, and other product- and CAPA-related reports.

7. Review the revisions or change control of all essential process parameters, equipment, materials, facility to essure impact analysis, accuracy and compliance throughout commercial life cycle.

8. Lead/support manufacturing investigations relevant to OOS, OOT, and incidents as required, including data evaluation, root cause analysis, identification, and establishing of the root cause using a data-driven and scientific manner.

9. Review the APQR and CPV (continuous process verification) reports, determine, support, and implement corrective measures, and interact with R&D as necessary for the enhancement of important quality attributes.

10. Perform basic statistical evaluations (Running Chart, I-MR Chart, Box plot, Regression analysis, Cpk and Ppk) of data and science based and logical interpretation of data. Experience in Minitab/JMP software.

11. Responding to internal as well as external audit observations with respect to manufacturing, process & validation related deficiencies.

12. Ensure technical training of the site manufacturing team concerning to CPPs, improvement in mfg. process and process controls.

13. Monitor the execution’s progress, seek for early warning indicators, and take prompt action to ensure the project’s timely completion (filing timeline, launch timeline, commercial release timeline).

14. Technical co-ordination with R&D/PDL/Production team for execution of Development/Exhibit/Process Validation batches/New Launches.

15. Coordination with cross-functional teams and assistance in resolving problems encountered during batch production and investigation (as required), assess timelines and ensure resolution as per the timelines.