Quality Specialist Gmp
Il y a 6 mois
QUALITY SPECIALIST GMP
- Biotechnology- 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 immunology.
The Quality Specialist GMP is an exempt level position with responsibilities for providing quality oversight over the production of a personalised cell therapy to support both clinical and commercial requirements in a sterile GMP environment.
- Serves as a quality specialist 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.
REQUIRED COMPETENCES & SKILLS
- Bachelor’s Degree in Science, Engineering or equivalent or relevant years of experience within the pharmaceutical industry
- 2 years relevant work experience is required, preferably within quality support in clinical manufacturing
- Knowledge of aseptic processing in ISO 5 clean room and biosafety cabinets
- Knowledge of GMP and FDA/EU regulations related to manufacturing of cell-based products
- Great attention to detail and structured/organised mindset to follow procedures
- Capable of working in a team environment with a positive attitude
- Experience with team-based collaborations
- Proactive
- Good written and verbal communication skills, ability to summarize and present results
- Problem-solving mindset
- Strong leadership skills to develop others and support
- Collaborate well with stakeholders (internal and external)
- Strong decision-making ability and think creatively while maintaining compliance and quality
- Ability to manage conflict and issues that arise with internal or external customers
- Working experience in an aseptic manufacturing facility is a plus
- 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
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