Team Member

3 days ago

Hyderabad, India Dr.Reddy's Full time

Preparation and revision of validation SOPs, qualification/validation protocols, reports for area, utility and equipments and when required.
- Preparation of FVMP. Equipment Life cycle management, Review of impact assessment, URS, SLIA, DQ, FDS, FAT, Risk assessment, SAT, MC, CTP, CLIA, IQ, OQ, PQ, UTM, VQ and revalidation documents.
- Area Qualification/Revalidation of new & renovated facility. Review and compilation of all area qualification/revalidation reports from engineering and QC. Support for execution of Test parameters (lux level, area recovery test, initial clean up time, power failure test, air flow visualization test, design room book verification, NVPC operation).
- Qualification of existing and new equipment’s and ensure that all validation activities are implemented as detailed in the validation protocol. Review and compilation of all qualification/revalidation reports.
- Updating and verification of equipment’s, area qualification revalidation calendar and online compliance of revalidation schedule.
- Representing validation during internal and external audits as SME.
- Imparting training of validation SOP’s and protocols to relevant personnel and departments.
- Media fill video and protocol review, preparation of media fill report, revision of media fill SOP & protocol
- Utility qualification of new facilities protocol preparation, execution and report preparation (water system & gases)

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