Manager-2

2 weeks ago

Vadodara, India Sun Pharmaceutical Industries Ltd Full time

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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