Alkesh Gajera

Bis 2025, Quality Assurance, Intas Pharmaceuticals Ltd
Frankfurt am Main, Germany

Skills

Quality Management
QMS
CAPA
Quality Planning
Test equipment management
Microsoft

Timeline

Professional experience for Alkesh Gajera

  • 3 years and 9 months, Aug 2021 - Apr 2025

    Quality Assurance

    Intas Pharmaceuticals Ltd

    ·Primary review of Equipment qualification (URS, SAT, FAT, Impact Assessment, DQ, IQ, OQ, PQ and facility qualification documentation. ·HVAC system validation, Water system, Compressed air and PSG Validation.

  • 1 year and 11 months, Sep 2019 - Jul 2021

    Quality

    cadila Pharmaceutical limited

    Preparation and execution of validation activities pertaining to: Qualification (DQ, IQ, OQ and PQ) of new Equipment and Utility (HVAC, pure steam, compressed Air). ·Periodic Re-qualification of existing equipment. ·Area requalification. ·Coordination with external service provider for execution of qualification activity.

Languages

  • German

    Basic

  • English

    Fluent

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