Quality Control (QC) Teamleader analytical
ROBERT WHITE is currently looking for an senior QC officer / QC Teamleader for one of our clients who is active in the immunotherapy and engineered T cell therapy industry. My client rapdily helping change the paradigm of cancer treatment and they revolutionizing individually tailor made treatments.
As the SeniorQC Officer/Teamleader for QC analytical you will be responsible for line management, supervision and coordination of a group of QC analysts (8-15 analysts) whose primary goal is to test commercial and clinical in-process samples, final drug product, incoming goods and stability samples.
In this role, you will lead a group (constisting out of 8-15QC Analysts) whose main task is to test in-process samples and final drug products while ensuring total cGMP compliance. The team lead will manage all resources (analysts, equipment, batches, documentation) to ensure timely delivery of high-quality analytical testing and reporting.
You will be involved in improvement projects of the lab and designing the processes that will make the QC laboratory more efficient and compliant as well as participate in building a team of qualified individuals. Due to the nature of the product and speed of treatment, this role requires a high level of proficiency and ownership of the process.
YOUR RESPONSIBILITIES
- Lead one of the QC analytical groups (approx. 8-15 analysts)
- Act as an advisor and technical resource to your team
- Coordinate and perform training of new personnel and manage training records for the QC analytical group
- Coordinate and work with the team to troubleshoot issues and provide solutions
- Organize and prioritize daily tasks to ensure an efficient process and timely analysis of batches
- Monitor the GMP systems currently in place to ensure compliance with documented policies and safety regulations
- Lead investigations and supporting continuous improvement initiatives
- Write, review and/or implement deviations, change controls and CAPAs
- Write, review and/or implement changes to controlled documents (SOPs, Specifications, Methods, etc.)
- Act as a SME during audits and Regulatory Inspections
- Interact with other departments and within QC in a professional manner and join in applicable meetings
- Support other groups within QC to reach the departmental goals
- Perform other duties as required by QC management
WHO ARE YOU?
- Full working knowledge of GMPs, pharmacopoeia and regulatory requirements
- Proficient in the application of QC principles, concepts, industry best practices and standards
- Management, organization and prioritization skills
- Strong interpersonal skills and willingness for teamwork
- Previous hands-on experience in a QC lab capacity
- Proficiency in quality control systems, methods and procedures for routine and non-routine analysis of raw materials
- Experience at performing and concluding investigations
- Experience in writing and implementing deviations, change controls and CAPAs
- Experience in writing or updating SOPs and analytical methods
- Strong verbal and technical writing skills (English)
- Experience with participating in audits (regulatory, customers, inter-organizational)
- Willingness and ability to work in shifts (day shifts, including Saturdays and Sundays)
INTERESTED?
if this sounds like your ideal new challenge of oppertunity, to hesitate and contact us via info@robertwhite.nl.
Dont want to wait until we contact you? upload your CV and contact directly via de website.
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