QC Validation Specialist
(6-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:
The position will be responsible for ensuring and maintaining high standards of quality and compliance within the client's organization.
In this role, you will be responsible for all or subset of the key responsibilities below:
- Perform/review laboratory system lifecycle management, including risk-based approach system qualification/retirement for laboratory computerized systems, commissioning/decommissioning, and periodic temperature mapping, in accordance with approved procedures and standard lead time.
- Lead and execute section and Quality improvement initiatives and other special projects, ensuring alignment with business goals and timelines.
- 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, 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.
- Support and respond to audit requirements and findings.
- Any other duties as assigned by reporting manager.
Requirements:
- Diploma or bachelor's degree in mechanical engineering or any other relevant engineering field
- At least 5 years of experience in computerized system validation (CSV) with experience in equipment qualification related to CSV
- At least 5 years of relevant working experience in GMP environment within the pharmaceutical/chemical manufacturing.
Reg No: R22104540
EA License no: 94C3609
