Analytical Quality Control Manager
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Netherlands.
• Responsible for develop in-process and final specification system for drug product and drug substance of cell therapy products.
• Manage the activities and department staff, transferring of validated methods from clinical site to commercial site.
• Responsible for reports on product release test monitoring of cGMP facility. You will also be responsible for updates on management trends.
Implement corrective action plans when needed.
• OTL and CMO tracking to complete lot disposition
• Responsible for conducting investigations for “out of specifications (OOS) results”.
• Responsible for Monitoring the GMP systems that are currently in place to ensure compliance with documented policies. Review proposed changes to
systems, methods ,procedures and submissions to regulatory agencies, when appropriate. Gather metric information for use in continuous
improvement of areas of responsibility. Give daily and weekly updates about the meetings
• Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies.
• Perform other duties as required.
• Responsible for managing the transfers and validation of analytical methods from Analytical Development to QC. Also from the transfer and validation
of methods to a contract-testing lab as well as transfer and validation of analytical methods.
• Responsible for validation of methods and tech transfer of methods, include comparability.
• Responsible for user requirements for purchase, qualification of analytical equipment. Work with internal and external resources to maintain
equipment in an optimal state.
• Responsible for qualifying biological reference standards and maintaining required cell cultures
• Monitor and trend data
• Complete routine record review of related documents and test data for in-process testing, drug product release and drug substance. Generation of
CoAs for product release.
• Responsible for communicating with agents from Regulatory agencies and participate in Pre-Approval Inspections.
• Develop, review and revise SOPs, qualification/validation protocols and reports.
• Manage and address deviations related to analytical procedures.
• Strong knowledge of GMP, SOPs and quality control processes.
• Identifying, writing evaluating and closing OOS’s and investigations.
• Experience with MS office
• English needs to be fluent(Strong written and verbal communication skills)
• Minimal PhD molecular biologist/ biochemist, 5-7 years of Quality Control experience or MS with 10 – 12 years of Quality Control experience.
• Strong knowledge of cell culture techniques.
• Equipment IQ/OQ/ PV/PQ
• Work independently with scientific/technical personnel.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jayton Tiao.
The Company
Our client is seeking motivated QC analytical manger that will be working in their commercial cell therapy production center located near North Holland. You will be responsible for the Quality Control team. In this role you will be reporting to the QC directors (hands-on resource reporting). You will also be responsible for providing Quality Control oversight of commercial manufacturing of final drug production. You will be responsible for validation of bioanalytical methods for cell therapy products, in-process, for raw material testing, stability, and final product testing, installation, for the purchase, installation, and qualification of QC instrumentation.Role Description
The company is seeking for a motivated to be build commercial cell therapy production center You will work with the Quality Control to support efforts in this exciting new area of cancer immunotherapy. You will be responsible for hands-on resource reporting to the Director QC.Responsibilities
• Responsible for testing process and specifications of raw materials.• Responsible for develop in-process and final specification system for drug product and drug substance of cell therapy products.
• Manage the activities and department staff, transferring of validated methods from clinical site to commercial site.
• Responsible for reports on product release test monitoring of cGMP facility. You will also be responsible for updates on management trends.
Implement corrective action plans when needed.
• OTL and CMO tracking to complete lot disposition
• Responsible for conducting investigations for “out of specifications (OOS) results”.
• Responsible for Monitoring the GMP systems that are currently in place to ensure compliance with documented policies. Review proposed changes to
systems, methods ,procedures and submissions to regulatory agencies, when appropriate. Gather metric information for use in continuous
improvement of areas of responsibility. Give daily and weekly updates about the meetings
• Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies.
• Perform other duties as required.
• Responsible for managing the transfers and validation of analytical methods from Analytical Development to QC. Also from the transfer and validation
of methods to a contract-testing lab as well as transfer and validation of analytical methods.
• Responsible for validation of methods and tech transfer of methods, include comparability.
• Responsible for user requirements for purchase, qualification of analytical equipment. Work with internal and external resources to maintain
equipment in an optimal state.
• Responsible for qualifying biological reference standards and maintaining required cell cultures
• Monitor and trend data
• Complete routine record review of related documents and test data for in-process testing, drug product release and drug substance. Generation of
CoAs for product release.
• Responsible for communicating with agents from Regulatory agencies and participate in Pre-Approval Inspections.
• Develop, review and revise SOPs, qualification/validation protocols and reports.
• Manage and address deviations related to analytical procedures.
Requirements
• Quality Control, GMPs, bioanalytical method validation.• Strong knowledge of GMP, SOPs and quality control processes.
• Identifying, writing evaluating and closing OOS’s and investigations.
• Experience with MS office
• English needs to be fluent(Strong written and verbal communication skills)
• Minimal PhD molecular biologist/ biochemist, 5-7 years of Quality Control experience or MS with 10 – 12 years of Quality Control experience.
• Strong knowledge of cell culture techniques.
• Equipment IQ/OQ/ PV/PQ
• Work independently with scientific/technical personnel.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jayton Tiao.
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