Senior Manager - 2

RESPONSIBILITY :

1. To evaluate Technology Transfer Data and documents.

1. Product Development Research (PDR) to Manufacturing Science and Technology Group (MSTG)
2. Site transfer dossier in case of site transfer products

1. Preparation, Review and approval of relevant documents for Dummy/Feasibility batch, Exhibit/Test batch, TTD, Pre PPQ and PPQ batches and other documents required for Regulatory filings

Example: Formulation order, Manufacturing Instruction, Process development Protocol/Report, Test batch Monitoring Protocol/Report, IPHT protocol/Report, Pre PPQ and PPQ Protocol and report.

1. Co-ordination with CFT and Execution of Feasibility / Dummy / IPHT/ Process development/ Exhibit/Test batches/Pre PPQ and PPQ batches.
2. Technology absorption from PDR during process development and Exhibit/Test batch execution and technology deliverance to Production.
3. Provide technical assistance and troubleshooting as and when required.
4. Preparation of Placebo.
5. Providing response to internal and external audits and Regulatory query response
6. Evaluation of Hold Time study.
7. Review and Approval of Change controls, SOP’s and specifications.
8. Timely initiation, review and closure of Change control, Deviation, Investigation, CAPA etc. in trackwise.
9. Review and approval of Continuous Process Verification reports, Post PPQ Protocol & Report, Annual Product review, Summary report to stage 1 of Process validation, stability protocols, URS, Equipment qualification protocol/reports.
10. To provide trainings on manufacturing instructions, SOP’s and awareness trainings related to deviations to concerned personnel based on requirement.
11. To carry out SAP related activities related to MSTG.

In absence of job holder, Sr. Officer / Executive/ Research Manager/Sr. Research Manager shall be responsible for all above activities in addition to her/his existing responsibilities.