Anuj Patel
Pharmaceutical Quality Specialist I Quality Engineer I CQV I QA I CSV I GxP I QMS I ALCOA+lCCSl Regulatory Compliance Work Authorization: Eligible to work in the United States without the need for employer sponsorship.
- Role
- Assistant Quality Assurance Manager at Krigen Pharmaceuticals
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Anuj Patel
Diligent, Ambitious, critical thinker, decision maker, Team worker and a target-oriented Quality Assurance Specialist monitoring quality issues, reviewing Corrective Action and Preventive Action, change control, OOT, Risk Assessment and maintaining standards in various firms, alongside designing quality regulations. Backed with 10 years of work experience in the pharmaceuticals industry, an expert in Quality management system & compliance and deviation management with proper improvements. Working in a result-driven mindset to deliver the needs of the stakeholders and keep company standards secured. Excellent verbal and written communication skills; able to deliver top-notch client interface and support while working effectively with members in a large team environmentSpecialties: GMP/GCP/GDP Audits, Batch review, Validation and Qualification, Computer system validation, Quality Management system, 21CFR 210,211,820
Experience
Assistant Quality Assurance Manager
Jan 2025 — Present · US
Leading Quality Management System implementation and CQV execution for a greenfield sterile injectable pharmaceutical manufacturing facility; responsible for commissioning and qualification of manufacturing equipment and instruments, regulatory compliance readiness and establishing site-wide quality governance aligned with FDA inspection standards.• Greenfield Quality System Implementation – Established site-wide Quality Management System including SOP frameworks, documentation control system and compliance monitoring processes.• CQV Program Leadership – Directing commissioning and qualification of manufacturing equipment and instruments through structured CQV lifecycle execution covering URS, FAT, SAT and IQ/OQ/PQ validation protocols.• Regulatory Compliance Readiness – Implemented GMP quality policies and inspection preparedness mechanisms supporting FDA audit readiness.• Document Management System Development – Built structured document management framework governing protocols, validation records and controlled documentation.• Team Formation & Capability Development – Built and trained quality team of 6 associates, establishing GMP knowledge base and operational readiness.• Audit & Inspection Readiness – Established compliance frameworks supporting internal audits, third-party inspections and future FDA regulatory reviews.
Education
Rajiv Gandhi University of Health Sciences
Bachelor's degree, Pharmacy
University of Dundee
Master in International Business and managment, International Business
2019 — 2020
Gujarat Technological University (GTU)
Master of pharmacy, Pharmacy
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