Job Description

Department Details

Role Summary

To work for MSAT (Manufacturing Sciences and Technology) downstream early phase projects.
The personal should support scale-up, technology transfer, PPQ (Process Performance Qualification) activities/documentation, Regulatory filing requirement studies/technical documents, CPV (Continues Process verification).

Key Responsibilities

1. Monitoring of Process and on floor support for manufacturing batches.
2. Coordinating with other departments for supporting manufacturing activities.
3. Adhering to EHS policies in respective areas and ensuring the compliance.
4. Ensuring cGMP compliance in respective areas.
5. Investigating the deviations/non-conformities to identify the root-cause and CAPA.
6. Implementing CAPA's to avoid recurrence of deviations/non-compliances.
7. Review process development and cGMP documents like SOP, batch manufacturing records, risk assessments, technical documents protocols and reports.
8. Assessing and mitigating the risks with respect to product, process, operations, equipment, facility and personnel.
9. Support production planning, inventory planning and control.
10. Supporting PE, EnM, Production teams for maintenance of the equipment and facility in a state of compliance with effective calibration, preventive maintenance and validation programs.
11. Support process and cleaning validation activities at scale.
12. Working on continuous improvement programs for operational efficiency and better compliance.
13. Authoring/ review of Continued Process Verification (CPV) protocol. Analysis of batch data and trends and summary of CPV report.
14. Authoring/ review of protocols and technical reports to support process changes, modifications, improvements and scale up to support implementation at manufacturing scale.
15. Authoring/Review of PPQ documents.
16. Authoring/Review of study protocols and reports for any trials to support the same.
17. Planning and scheduling of lab scale batches for scale down experiments.
Authoring/ review of comparability protocols and reports.
18. Data compilation, analysis & presentations to reporting manager and cross functional teams.
19. Contribute at team discussions of CMC and other decision-making forums for development, clinical and commercial manufacturing.

Educational Qualifications

Required Education Qualification: M.Tech
Required Experience: 3 - 8 years