Functieomschrijving

ALTEN develops and delivers Life Sciences expertise to leading companies in the world. Today, ALTEN Belgium is a major player in Life Sciences (Pharmaceutical, Medical Devices, Biotechnologies) with 30 customers in Flanders. As a global player with a local presence, we are flexible and able to adapt to the needs of each customer. We are looking for a motivated Industrial Pharmacist / Qualified Person to ensure the release of batches of pharmaceutical products. The ideal candidate will be responsible for quality assurance and regulatory compliance, ensuring that products meet the highest standards of quality and safety before they are released to the market. As an ALTEN consultant, you will have the opportunity to be part of the following activities: Ensure the release of batches of pharmaceutical products in accordance with local and international regulations Act as the quality assurance representative to approve production activities and associated documentation Perform critical reviews of batch records, including certificates of analysis, manufacturing and control protocols, and test reports Work closely with production, quality control, and pharmaceutical development teams to ensure the quality of pharmaceutical products Ensure that facilities, equipment, processes, and procedures are in compliance with quality and safety standards Participate in incident, deviation, and change management, and conduct quality investigations Maintain a thorough knowledge of local and international regulations related to batch release and regulatory compliance

Vereisten

Je hebt een master of PhD met voorkeur industrieel ingenieur, bio-ingenieur of farmaceutische wettenschappen Je hebt reeds praktische ervaring binnen GMP Je beschikt over goede communicatieve en sociale vaardigheden Je vindt het interessant om je vertrouwd te maken met het proces / de technologie Binnen uiteenlopende projecten maakt jouw kennis het verschil Je vindt het leuk te blijven leren en ook om jouw collega’s te helpen Je neemt ownership over je eigen werk en bent flexibel om de vooropgestelde deadline te behalen

Must-have

• Master
• Master (MA)

Nice-to-have

• 2 jaar relevante ervaring,
• Een project leiden

  Domein: Productiemethodes

  Domein: Procesmethodes

  Domein: Continue verbetering

  Domein: Industrialisatiemethodes
• Doelgericht handelen.

  Ontleden van een probleem en aanvullende informatie zoeken.

  Gedrag of werkwijze gemakkelijk aanpassen aan veranderende situaties en verschillende personen.

  Samenwerken om tot een gezamenlijk resultaat te komen.

  Taken uitvoeren zonder ondersteuning of toezicht van anderen.

  Handelen in overeenstemming met de waarden en normen van de organisatie.

  Doelen en prioriteiten bepalen en aangeven hoe ze te bereiken.

  Informatie en ideeën schriftelijk of mondeling overbrengen.

  Meningen en hun gevolgen tegen elkaar afwegen aan de hand van relevante criteria.
• Engels

  Nederlands

Wij bieden

Required Skills and Qualifications: Master's degree in pharmacy or a related field Qualified Person (QP) certification in compliance with local and international requirements, or in the process of obtaining it No minimum professional experience requirement outside of the internship for obtaining the QP number Excellent written and verbal communication skills to interact with team members, customers, and business partners Ability to work independently and as part of a team to solve problems and achieve quality and regulatory compliance goals Strong analytical and problem-solving skills, with particular attention to detail Thorough knowledge of local and international regulations related to batch release and regulatory compliance Knowledge of quality standards and regulatory compliance procedures for pharmaceutical product manufacturing If you see yourself in this position, then you are the one we are looking for! ALTEN offers a challenging environment where through the diversity of projects your growth is key. We also believe that as a consultant you never stop learning, which is why we give you the opportunity to further develop both personally and professionally. Within our ALTEN Academy we offer training that matches your ambitions.

Groei met ons mee

Bedrijfsinformatie

Sollicitatieprocedure