Knowledge of Process validations and new product Introduction.
Experience in Nasal formulations.
PPQ Protocols, Reports review, Risk Assessments review approval.
Performing in-process activities such as line clearance, In-process checks, AQL checks, and collection of Samples (blend /Finished product/stability samples ).
Sampling .and reconciliation of packing material and finished goods products during packing operation.
Review of Batch Production/packing Records.
Investigate incidents, OOS, and OOT and ensure action plans.
To ensure cGMP (Current Good Manufacturing Practices) compliances on the shop floor.
Understand manufacturing and packing equipment and its function.
Review Equipment’s Alarm, Event, and Audit trail
B. Pharmacy / M Pharmacy/ MSc
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