Quality Assurance / Quality Specialist / Quality Engineer #HMS

Quality Assurance / Quality Specialist / Quality Engineer

Company Overview

Location: Kranji (near MRT with a 5-minute shuttle bus)

Number of Openings: 9
Duration: 6-month
Salary: up to 8K

Job Responsibilities:

1. Documentation and Quality Oversight:Revise, review, and approve SOPs, MBR/EBR, and QO documents.
   Provide quality guidance and support to the manufacturing team, addressing quality queries and issues.
   
2. GMP and Compliance:Conduct quality oversight activities, including GEMBA and GMP walks.
   Adhere to and enforce cGMP and regulatory requirements, especially for FDA and EU compliance.
   
3. Qualification/Validation Support:Perform IQ/OQ tasks and assist in validation activities including Data Integrity, Analytical Instrument Qualification, Analytical and Microbiology Method Validation, and Critical Reagent Qualification.
   Review and approve related protocols, reports, and ensure alignment with regulatory requirements.
   
4. Project Involvement and Collaboration:Act as the Quality Representative in cross-functional projects.
   Provide validation expertise and maintain Master Validation Plans.
   Collaborate on multi-site initiatives to harmonize Quality Systems across plants.
   
5. Documentation Integrity and Inspection Readiness:Ensure documents are clear, compliant, and defendable during audits.
   Support multisite initiatives to align validation activities across locations.
   
6. Other Responsibilities:Build and maintain partnerships with internal departments.
   Adhere to EHS requirements and Shire’s Code of Conduct.
   

How to Apply: Send your resume to Jocelyn Chan at [email protected] or contact via Telegram @jocelynchan.

Jocelyn Chan | Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience) Company EA Licence Number: 99C4599 Personnel EA License: R1331820