 - https://sketch.com --%3E%3Ctitle%3EPath%3C/title%3E%3Cdesc%3ECreated with Sketch.%3C/desc%3E%3Cg id='Page-1' stroke='none' stroke-width='1' fill='none' fill-rule='evenodd'%3E%3Cg id='start-people-(1)' fill='%23FF6600' fill-rule='nonzero'%3E%3Cpath d='M23.8690431,11.988 C23.8690431,18.569 18.515,23.9220489 11.934,23.9220489 C8.76716425,23.9310904 5.72846969,22.67211 3.496,20.426 C1.25036257,18.1932135 -0.00853219063,15.1547255 -4.30890961e-05,11.988 C-4.30890961e-05,8.8 1.241,5.802 3.496,3.549 C5.72901486,1.30382392 8.76744106,0.0453148487 11.934,0.0539494455 C15.1006691,0.0447567941 18.1393018,1.3033514 20.372,3.549 C22.6182512,5.78186548 23.8775351,8.82078358 23.8690431,11.988 Z M20.301,8.036 C18.915,7.029 17.914,7.769 17.03,8.422 C16.167,9.062 15.42,9.614 14.361,8.845 C13.303,8.076 13.597,7.195 13.939,6.176 C14.288,5.134 14.682,3.954 13.295,2.947 C12.4863641,2.34514112 11.3786359,2.34514112 10.57,2.947 C9.892,3.441 9.542,4.177 9.56,5.074 C9.595,6.726 10.811,8.508 11.968,9.276 C13.073,10.011 13.693,10.911 13.712,11.811 C13.725,12.45 13.419,13.03 12.849,13.444 C12.279,13.858 11.633,13.969 11.029,13.76 C10.179,13.463 9.515,12.597 9.157,11.318 C8.784,9.981 7.465,8.273 5.904,7.73 C5.057,7.435 4.249,7.541 3.568,8.035 C2.74602094,8.61800943 2.40377802,9.67115835 2.726,10.626 C3.256,12.256 4.5,12.245 5.599,12.235 C6.674,12.226 7.603,12.218 8.007,13.462 C8.411,14.706 7.654,15.245 6.779,15.87 C5.885,16.509 4.873,17.23 5.402,18.86 C5.70283511,19.8217237 6.59837875,20.4726588 7.606,20.462137 C9.32,20.462137 9.694,19.274 10.024,18.228 C10.347,17.203 10.628,16.317 11.935,16.317 C13.244,16.317 13.522,17.203 13.846,18.228 C14.176,19.275 14.55,20.462137 16.264,20.462137 C17.2717263,20.472988 18.1674456,19.8219252 18.468,18.86 C18.998,17.23 17.985,16.506 17.091,15.87 C16.216,15.245 15.46,14.706 15.862,13.462 C16.266,12.217 17.195,12.227 18.27,12.235 C19.369,12.244 20.612,12.255 21.142,10.626 C21.4639329,9.67167381 21.1221673,8.61914963 20.301,8.036 L20.301,8.036 Z' id='Shape'%3E%3C/path%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
Pharma
Investigation expert
Description de fonction
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:
- 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.
Profil
Who are we looking for?
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.
Offre
What we offer for the role of Investigation Expert:
- 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!
Information
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.