Location: Kranji (Near MRT, 5-minute shuttle bus)
Contract Duration: 6 months (with potential extension)
Key Responsibilities:
- Revise and review Standard Operating Procedures (SOPs)
- Review executed Master Batch Records (MBR) and Electronic Batch Records (EBR)
- Provide quality support and interpretation to the manufacturing team on quality-related queries and issues
- Participate in GEMBA and GMP walks for quality oversight
- Archive Quality Operations (QO) documents and support IQ/OQ activities
- Contribute to User Requirement Specifications (URS) and design specifications
Primary Job Objectives:
- Support the implementation and maintenance of quality systems
- Provide quality oversight for validation-related activities, including data integrity
- Ensure compliance with internal procedures and regulatory requirements, including FDA/EU cGMP and ICH guidelines
Requirements:
- Minimum of 2-3 years of experience in pharmaceutical/biotechnology quality assurance, manufacturing, or validation (preferably in multinational companies)
- A degree in pharmaceutical sciences, life sciences, biotechnology, chemistry, chemical engineering, or related fields. Certification in Quality Engineering or Validation topics is a plus
- Hands-on experience with equipment, process, cleaning, computer systems & shipping validation is advantageous
- Knowledge of FDA/EU cGMP, CFR 21 Part 11, and ICH guidelines is essential
- Strong problem-solving skills and ability to interact effectively with cross-functional teams
- Excellent verbal and written communication skills
All qualified applicants, please click “ APPLY NOW”
Or you may send in your resume to:
Whatsapp: https://wa.me/+6597430026
Email : [email protected]
Kimmy Low Yi Ting (Kim) | CEI Registration Number: R23112122
Recruit Express Pte Ltd Company Reg. No. 199601303W | EA LICENCE Number: 99C4599
