Manager 2

Year Vadodara, Gujarat, India

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Handling of filter validation activities including review of PPQ form, filterability trial documents, filter validation protocol and report.
To keep track of filter validation activity.
To review risk assessment reports for extractable and leachable study.
Review of product development documents
Review of tech-transfer documents.
Review of regulatory submission documents.
Review of Elemental and Nitrosamine impurity risk assessment
Review of all in-process, finished product & stability specification.
Preparation and review of system & instrument SOPs & Guidelines.
Review of Investigation, justification or evaluation protocols/reports.
Handling of training matrix.
Review of Lab note book of critical projects on regular basis.
Review of DCGI / domestic market submission documents.

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