Contract QA Project Specialist (CSV) - Pharm / West #HHL

Roles & Responsibilities

Lead quality assurance oversight for computer system validation (CSV) projects within a GMP environment, ensuring compliance with regulatory standards and driving successful system upgrades and implementations.

Responsibilities

• Lead QA oversight for computer system validation (CSV) activities ensuring compliance with cGMP, GAMP 5, 21 CFR Part 11, and Annex 11 standards
• Review user requirement specifications (URS) and risk assessments to ensure thorough validation planning and risk mitigation
• Oversee installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities to verify system functionality and compliance
• Ensure data integrity by applying ALCOA+ principles and managing change controls throughout validation and implementation processes
• Act as the QA representative for system upgrades and new system implementations, collaborating closely with IT, Validation, and Engineering teams to drive project success
• Apply strong CSV and QA project management skills to deliver compliant and efficient validation outcomes within a GMP environment, preferably in pharmaceutical or biologics sectors

If interested, please email me at alexgoh@recruitexpress.com.sg or telegram @alexgohhl

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Alex Goh Hock Leong

(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)

Tell employers what skills you have

Management Skills
Quality Assurance
Quality System
Healthcare
GMP
GAMP
Auditor
Computer System Validation
Compliance
Project Management
ISO 9001
Manufacturing
Audit