QA Investigator

QA INVESTIGATOR
- Biotech- GhentWHAT IS OFFERED

Be part of an international and diverse team, whilst developing one of the breakthrough innovations within healthcare and technology.

This is a unique opportunity to have impact, write history and challenge yourself in a highly novel environment.

ABOUT THE COMPANY

MindCapture supports in the recruitment of this talent for a global biotech company that’s developing, manufacturing and commercializing new cell-based therapies to battle cancer with focus on personalized immunological therapies.

The **QA Investigator** is an exempt level position with responsibilities for providing quality oversight over the production of cell therapies 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.
- 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 mínimal 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.

REQUIRED COMPETENCES & SKILLS
- Bachelor’s Degree in Science, Engineering or equivalent or relevant years of experience within the pharmaceutical industry
- 3-5 years relevant work experience is required, preferably within aseptic manufacturing (quality assurance, manufacturing compliance, clinical quality, cell therapy, )
- 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.
- Ability to pay attention to details and follow the procedures.
- 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.
- Fluent in Dutch and English

**Important: this challenge is within a shift schedule, with the advantage of working 4 days per week (10 hours/day) with 4 days off. Shifts include routine weekend and evening work as required by the process. This shift system can help you avoid traffic and reduce time spend in the car.