QC Specialist (Equipment Qualification & GMP) HDCC
recruit express pte ltd- Posted an hour ago
- Be among the first 10 applicants
Job Description
Be Part of a Leading Biologics Manufacturing Environment!
Are you an experienced QC professional with a strong background in GMP and equipment qualification Here's an opportunity to take on a pivotal role in supporting laboratory compliance, equipment qualification, and quality excellence within a global biopharmaceutical manufacturing environment!
Key Responsibilities
- Develop, review and execute qualification protocols for QC laboratory equipment to ensure compliance with GMP requirements.
- Support equipment qualification activities, including testing, documentation and verification of qualification results.
- Perform control trending and critical material qualification activities to maintain laboratory quality standards.
- Provide QC system administration support and work with laboratory systems such as LabWare and MODA.
- Ensure equipment qualification activities align with applicable regulatory requirements and internal quality procedures.
- Coordinate qualification projects, track progress and ensure timely completion of deliverables.
- Maintain accurate documentation and collaborate with cross-functional teams to support inspection readiness and operational excellence.
Requirements
- Relevant experience in the pharmaceutical industry, with a sound understanding of GMP requirements.
- Hands-on experience in QC equipment qualification, including writing qualification protocols, is essential.
- Experience with equipment such as TOC analysers and microplate readers will be an advantage.
- Familiarity with control trending, critical material qualification, LabWare and MODA.
- Experience in QC system administration and basic knowledge of regulatory requirements for equipment qualification.
- Strong project management, documentation and communication skills.
Interested candidates, please submit your CV to [Confidential Information]
Leon Leong De Cong
CEI Reg. No.: R1551708
Recruit Express Pte Ltd
EA Licence No.: 99C4599
More Info
Key Skills
Inspection Engineering Management
Specification of Equipment
medical diagnostic equipment
Laboratory Equipment Maintenance and Calibration Management
Good Written Communication Skills
Control Practices
Timely Delivery
Qualification Process
Materials Qualification
GMP Environment
