TST Head- FTO OSD Fresher's job

Ensure scientific assessment into the “Manufacturability” of the product and ensure for a robust process development during new product introduction, product site transfer and process validation

Review of technical risk assessment studies for process scale-up and appropriate risk mitigation plan and implement

Monitor product performance and transition into technical operation through review and approval of annual product Reports, Continuous Process verification reports.

Conceptualize and implement metrics for assessment of Product robustness & continuous process verification (CPV)

Conceptualize and implement automation/ digitization solutions in this area in consultation with other stakeholders

Ensure cleaning validation adherence to Validation Master Plan and respective Cleaning validation SOP’s as well as cGMP & Regular requirements.

Ensure that validation, contamination control and cleaning validation policy is in line with current regulatory / quality expectations (together with SME’s).

Ensure updation of cleaning validation matrix.

Ensure effective implementation of Quality management system (CAPA, Incidents, Investigations, OOS/OOT and Change controls) in MSAT

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