Overview
Position: Analytical Technical Specialist
Location: Terumo BCT Ltd
Reporting To: Analytical Technical Lead
Overall Objectives: The post holder, as part of the Compliance and Remediation team, will work closely with the laboratory teams to drive improvements to laboratory operations at Terumo BCT Ltd., to provide technical expertise and support within the laboratory environment, ensuring that testing and analytical procedures comply with regulatory and quality standards.
Responsibilities
* Demonstrates full understanding of routine laboratory procedures
* Provide technical guidance for analytical methods, equipment and troubleshooting
* Use a risk-based approach to identify and execute method improvements and remediations
* Through the change control process, assess any customer or regulatory impact with method remediations or document updates
* Standardise document formatting (IAMs/SOPs/specs) and optimise laboratory processes
* Support method development, validation, and verification activities
* Write and/or revise Standard Operating Procedures (SOPs), procedures and specifications
* Ensure laboratory operations comply with GMP, GDP, and all relevant regulatory requirements
* Regular review of pharmacopeial updates to assess impact to in-house procedures
* Works closely with laboratory teams on root cause analysis and resolution of non-conformances and analytical method issues
* Support in the development of theoretical and practical laboratory training materials and training programme
* Foster a culture of accountability, safety, and continuous learning
* Promote a culture of quality, compliance, and continuous improvement across teams
Qualifications
* Chemistry Degree
* Quality Laboratory Experience
* Method Development & Troubleshooting
* Creating SOPs
Benefits
* Performance Bonus
* Healthcare Cash Plan
* Annual Leave
* Employee Assistance Program
* Life Assurance
* Income Protection
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