RSS export of vacancies - Nur Top-Jobs : No / Standort : Europe-->Belgique-->Flandres-->Flandre orientale

2023-26479 - QC Analyst

Mon, 28 Apr 2025 08:29:25 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Role Overview The QC Analyst is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. Major Responsibilities: Responsible for the completion of QC testing related to the manufacturing of autologous products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations. Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products. Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories. Perform peer review/approval of laboratory data. Utilize electronic systems (LIMS) for execution and documentation of testing. Create, review and approve relevant QC documents, SOP’s and WI’s. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties will be assigned, as necessary

Education: A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry. Experience: A minimum of 1-2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Capabilities, Knowledge, and skills: Experience in a Quality Control setting is preferred. Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required. Knowledge of Good Tissue Practices is required. Detailed knowledge of QC test methods and related equipment is preferred Excellent written and oral communication skill are required Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process. Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice. The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision. Comfortable with speaking and interacting with inspectors. This position may require occasional travel to partner sites in NJ or PA as business demands. This position may require up to 10% domestic or international travel as business demands. Language(s): English
Location : Brugge

2023-26478 - QA Investigator

Mon, 28 Apr 2025 08:29:04 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Role Overview: The QA Investigator is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and compliant product supply. Major Responsibilities: Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues. Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints. Perform analysis on quality indicating data and identifying trends. Collaborates with functional departments to resolve issues. Manage cross-functional projects with many stakeholders. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes. Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities. Routinely recognize and resolve quality issues. Seek management guidance on complex issues. Drive continuous improvement.

Education: A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required. Experience: A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Key Capabilities, Knowledge, and Skills: Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices. Strong interpersonal and written/oral communication skills. Ability to quickly process complex information and often make critical decisions with limited information. Proficient in applying process excellence tools and methodologies. Ability to pay attention to details and follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a requirement. Ability to work with others in a team environment. Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing. Ability to identify/remediate gaps in processes or systems. Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred. Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint). Language Requirements: Dutch and technical English
Location : Ghent

2023-26480 - QC Investigation Specialist

Mon, 28 Apr 2025 08:24:39 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Role Overview The QC Investigation Specialist is an exempt level position with responsibilities for leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. Major Responsibilities: In this function you will be responsible to manage the QC related deviations and execute qualitative investigations in close collaboration with the analysts and the involved stakeholders according to the required procedures. Ensuring thorough root cause analysis is performed using the correct tools and proper CAPAs are defined in order to reduce non-conformances and deviations in the future. Different tasks are (but are not excluded to) Review/complete routine manufacturing and QC nonconformance/deviation investigations. Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise. Proactively work with stakeholders to implement effective CAPAs and to ensure the timely completion of corrective and preventive actions within the laboratories. Provide recommendations for the improvement of processes by working cross functionally with multiple stakeholders. Work closely with management to propose/execute improvements through the change management system. Drive continuous improvement. Ability to respond with a high degree of urgency to departmental and cross functional needs and requests. Reporting/Monitoring metrics on non-conformance investigations and corrective and preventive actions (CAPA). Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Comply with all training requirements to perform duties on the job.

Education: A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required and relevant years of experience within the pharmaceutical industry. Experience: A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, manufacturing compliance, clinical quality, or cell therapy. Capabilities, Knowledge, and skills: Experience in a Quality Control setting is preferred. Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required. Knowledge of Good Tissue Practices is required. Detailed knowledge of CAR-T QC test methods and related equipment is preferred. Excellent written and oral communication skill are required. Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process. Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice. The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision. Comfortable with speaking and interacting with inspectors. Language(s): Dutch & English
Location : Ghent

2023-26496 - QC Manager

Mon, 28 Apr 2025 08:24:20 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Role Overview The Associate Manager/Manager, Quality Control is an exempt level position with responsibilities for managing the operation and worklflow of the quality control laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects. Major Responsibilities: Ensuring adequate training (skills-based, cGMP and safety) of associates within the department. Raw material, in-process, environmental/utility, product release, and stability testing. Investigation of laboratory non-conformances (events, deviations, and invalid assays). Maintenance, calibration and qualification of laboratory instruments and equipment. Test method verification, qualification, validation and/or transfer activities in the QC laboratories. Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing. Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations. Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on the-job training requirements. Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs. Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision. Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties will be assigned, as necessary

Education: A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required. Experience: A minimum of 8 to 10 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 1 to 4 years of leadership experience is also required. Capabilities, Knowledge, and skills: Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices. Strong interpersonal and written/oral communication skills. Proven people management and leadership experience is required. Experience working with quality systems is required. Extensive knowledge of chemical, biochemical and microbiological concepts is required. Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred. Ability to quickly process complex information and often make critical decisions with limited information. Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities. Proficient in applying process excellence tools and methodologies. The candidate must be highly organized and capable of working in a team environment with a positive attitude. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a requirement. Experience developing and setting long-term objectives. Ability to identify/remediate gaps in processes or systems Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred. Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint). This position may require up to 10% domestic or international travel as business demands Language(s): Dutch
Location : Ghent

2023-26503 - Quality Person In Plant

Mon, 28 Apr 2025 08:24:03 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Role Overview: The Quality person in plant is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. Job duties are performed within a team according to an assigned, production shift schedule. This role will work in shift regimes supporting the 7/7 days cell processing. Major Responsibilities: Serves as a Quality person in plant in support of cell therapy manufacturing. Ensures Quality Oversight in plant covering various process related activities Performs periodic Quality checks/audits related to process, documentation and process manipulations Strive to reduce non-conformances and deviations in supported areas by proactively driving compliance. Responsible for real time review of process documentation in support of process unit operations and release activities where needed. Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues. Supports in accurate and timely input, investigation and review of manufacturing deviations, CAPAs, change controls and complaints. Review and approve manufacturing procedures and batch records Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Support regulatory inspections and audits by ensuring inspection readiness within facility. Perform internal housekeeping audits. Other duties will be assigned, as necessary.

Education: A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry. Experience: A minimum of 2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 2 years of experience with quality support in clinical manufacture is preferred. Key Capabilities, Knowledge, and Skills: Aseptic processing in ISO 5 clean room and biosafety cabinets. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Must exhibit strong leadership skills and effectively develop others. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and to communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process. Language Requirements: Dutch and technical English
Location : Ghent

2023-26499 - QC Sample Coordinator

Mon, 28 Apr 2025 08:21:19 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Role Overview The QC Sample Coordinator, is responsible for sample management. The QC Specialist is encouraged to work independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically and acts decisively. Major Responsibilities Prepares and reviews documentation independently Responsible for QC sample and retain management Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS) Prepare documents and coordinate Sample shipment (internal and external shipments) Review logbooks and/ or LIMs to align physical quantities of samples in freezers/refrigerators Periodic inspection and consolidation of retains Document and perform sample management related non-conformance investigations Document and handle corrective and preventative action records Supports internal and regulatory audits

Requirements A minimum of a Bachelor’s degree or higher A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry A degree in Biology, Biochemistry, Microbiology, Chemistry or related field Solid understanding of regulatory requirements, policies and guidelines Experience with Quality Control document reviews and regulatory inspection processes Working knowledge of Quality systems Experience in management of retain samples using electronic systems (eLIMS) Candidates must be able to accommodate shift schedule. Shifts include weekend and evening work as required by the manufacturing process This position will be located in Ghent and may require up to 5% of travel This position will occasionally require to lift up to 10 kg Language Requirements: Dutch and Technical English
Location : Ghent