
fathe mohammad shaik shaik
Pharmaceutical / Bio-tech
About fathe mohammad shaik shaik:
My self fathe Mohammad shaik
Experience
I am writing to express my interest in the Engineering Projects and operations . With 15 years of extensive experience in pharmaceutical engineering projects, commissioning, qualification (CQV), and validation, I bring a proven track record of delivering complex projects involving process equipment, water systems, utilities, and HVACin compliance with stringent regulatory standards.
My expertise includes:
- Process Equipment & Utilities: End-to-end management of equipment selection, installation, commissioning, and qualification for injectables, oncology, and oral solid dosage facilities.
- Water Systems & HVAC: Successful execution of IQ, OQ, PQ for water systems (RO, EDI, WFI, pure steam) and HVAC systems, ensuring ISO 14644 compliance and GMP standards.
- Project Leadership: Skilled in managing brownfield and greenfield projects, coordinating cross-functional teams, and implementing containment strategies for oncology facilities.
- Regulatory Compliance: Hands-on experience with USFDA, GMP, and QMS requirements, ensuring audit readiness and robust documentation (URS, DQ, IQ, OQ, PQ).
Education
Btech jntu kakinada
MBA IN OPERATIONS AND PRODUCTION MANAGEMENT
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