U. Manmohan Patro
Assistant Manager in Quality Assurance | Ensuring Product Quality & Regulatory Adherence
- Role
- Assistant Manager Quality Assurance at Viatris
- Location
- Indore, MP, IN
- LinkedIn followers
- 500 followers
About U. Manmohan Patro
Highly motivated Quality Assurance professional with 11+ years in pharmaceuticals. Proven track record in ensuring superior product quality and regulatory compliance across diverse QA functions, including:IPQA Leadership: Successfully managed batch releases, implemented Change Control, reviewed unit operations for tablets and topicals, upholding rigorous standards in manufacturing and packaging.Validation Expertise: Developed and executed CSV documents, Validation Plans, System Requirement Specifications, and protocols (Risk Assessments, IQ/OQ/PQ). Authored critical deliverables ensuring compliance.Regulatory Compliance : Navigated complex regulations (GAMP 5, 21 CFR Part 11, EU Annexure 11) and led comprehensive 21 CFR Part 11 assessments.Continuous Improvement : Managed CAPA deviations, implemented mitigation strategies, and oversaw QMS activities to optimize operations.
Experience
Assistant Manager Quality Assurance
Mar 2024 — Present · Indore, IN
Experienced Assistant Manager in Quality Assurance adept at overseeing In-Process Quality Assurance (IPQA), Change Control, Annual Product Quality Review (APQR), Validation, Computer Systems Validation (CSV), SOP preparation, cGMP compliance, Calibration, Hold Time Sampling, and Quality Management System (QMS) implementation. Demonstrated ability to ensure adherence to regulatory standards, enhance product quality, and optimize operational efficiency through effective QA practices.\"
Education
Biju Patnaik University of Technology, Odisha
Bachelor of Pharmacy, Pharmaceutical Sciences
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