QC Validation Specialist
(12 month contract)
About the Company:
Our client is a US healthcare and a leading global biopharmaceutical company. They have a revenue of US $40.1 billion, with more than 69,000 employees across 140 countries with a heritage of more than 125 years. Our client is committed to provide patients and customers with a reliable supply of high-quality, safe, and effective medicines and vaccines. Their global supply strategy relies on manufacturing capabilities and expertise to achieve this mission
Primary Responsibilities:
- Perform/review system qualification, requalification, relocation, decommissioning and retirement for laboratory equipment in accordance with approved procedures and standard lead time.
- Assume role of Subject-Matter-Expert of laboratory system lifecycle, collaborates closely with cross-functional teams and above-site functions. This includes initiating alignments proactively, sharing expertise, and providing input to ensure alignment and consistency across the organization.
- Author/review Quality Notifications and Test Exception Reports, lead root cause analysis and ensure effective implementation of related actions within the agreed timeframe.
- Conduct troubleshooting of laboratory system lifecycle, identifying and resolving any issues that may impact the business/work efficiency and compliance.
- Identify opportunities and propose solutions to improve efficiency and compliance in processes, standards, and best practices within the team.
- Provide leadership, expert guidance and support to team members, acting as a go-to resource for problem-solving and decision-making.
- Provide skills training to other team members, ensuring they have the necessary knowledge and competencies to perform their duties effectively.
- Any other duties as assigned by reporting manager.
Requirements:
- Diploma or bachelor's degree in chemical engineering or any other relevant engineering field
- At least 5 years of experience in qualification, requalification, relocation, decommissioning and retirement of Good Manufacturing Practice (GMP) Lab equipment (not limited to Ultraviolet-Visible (UV-Vis) Spectrometer, Total Organic Carbon (TOC) Analyzer, Microplate Reader, Liquid Particle Counter, Capillary Electrophoresis (CE), High Performance Liquid Chromatography (HPLC), Analytical Balances, Incubators, Particle Counters)
- Experience in GMP environment within the pharmaceutical/chemical manufacturing.
Reg No: R22104540
EA License no: 94C3609
