Onze klant, een biotech bedrijf, gevestigd in Zwijnaarde, is een wereldwijd biotechnologiebedrijf dat de innovatieve CAR-T celtheraptie naar Gent brengt. Het bedrijf maakt hiermee dagdagelijks het verschil in het leven van vele patiënten die lijden aan kanker en andere levensbedreigende ziektes.
Ze zijn momenteel in een fase van sterke groei en zoeken gemotiveerde en toegewijde teamleden.
Ze zijn momenteel in een fase van sterke groei en zoeken gemotiveerde en toegewijde teamleden.
Investigation expert
Functieomschrijving
Our client’s Operations team in Ghent is looking for a driven Investigation Expert. In this dynamic role, you will dive deep into investigations to identify and resolve issues in our client’s production process caused by human error. Your work will be crucial in ensuring that products are safe and released on time.
Are you driven by quality and ready to make a difference in personalized medicine? Then this is your chance to shine!
What can you expect from the role?
As an Investigation Expert with our client, you will have a challenging and varied set of responsibilities. Here’s what you’ll do:
Are you driven by quality and ready to make a difference in personalized medicine? Then this is your chance to shine!
What can you expect from the role?
As an Investigation Expert with our client, you will have a challenging and varied set of responsibilities. Here’s what you’ll do:
- Conduct Operational Investigations: You will perform in-depth investigations to quickly identify and resolve the causes of incidents due to human error in the production process. This ensures safe and timely product releases. You will also implement robust investigation methods and train the team to efficiently handle quality investigations.
- Quality and Compliance: You will ensure that all investigations meet the highest GMP standards and regulatory requirements. You will take the lead in investigating and reporting deviations and support other departments in deviation investigations. You will apply and support corrective and preventive actions (CAPAs).
- Primary Point of Contact: You will act as the primary contact for regulatory agencies during inspections and confidently defend investigation strategies and reports.
- Continuous Improvement: You will maintain and lead the investigation dashboard, support QEM systems, and implement process improvements based on lessons learned.
- Build Strong Collaborations: You will build sustainable relationships with various stakeholders to ensure smooth handling of investigations.
Profiel
Who are we looking for?
Education:
Experience:
Languages:
Strengths:
Expertise:
Education:
- You have a master’s degree in (bio)engineering, science, pharmacy, or another related field of study, or you are equivalent through experience.
Experience:
- You have at least 3 years of experience in project execution within an operational cGMP or ATMP environment in the biotech or pharmaceutical industry. Previous experience in manufacturing, quality, or engineering is essential.
Languages:
- You are proficient in both Dutch and English, with strong written and oral communication skills.
Strengths:
- You are an enthusiastic team player, eager to learn, and willing to tackle complex technical and scientific challenges.
- You have excellent organizational, analytical, and scientific writing skills.
- Your proactive, positive, and flexible attitude makes it easy to build strong partnerships.
Expertise:
- You have knowledge of cGMP regulations and FDA/EU guidelines related to ATMPs. Experience with risk assessment and root cause analysis is a plus.
Aanbod
What we offer for the role of Investigation Expert:
Are you ready to make a difference in an innovative biotechnology environment? Apply now and join our client’s team dedicated to improving lives!
- A job with impact that directly contributes to the well-being of patients worldwide.
- An excellent work-life balance with day shifts.
- A supportive and innovative work environment where learning and personal development are valued and encouraged.
- The opportunity to work with people from all over the world.
- A permanent contract and an attractive salary package, complemented by various fringe benefits, such as additional statutory holidays, meal vouchers, group and hospitalization insurance, double holiday pay, a year-end bonus, and a performance bonus.
- Many fun and informal events.
Are you ready to make a difference in an innovative biotechnology environment? Apply now and join our client’s team dedicated to improving lives!
Praktische informatie
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