Anacura is an independent laboratory group of 250 employees consisting of Anabiotec, active in drug development, and Labo Nuytinck, active in extramural laboratory medicine.
It is the vision of Labo Nuytinck that an individual's health is served by their own strength and insight, supported by a circle of trusting professionals. We dream of an ecosystem in healthcare in which various partners – general practitioners, other healthcare providers and laboratories – guarantee qualitative and affordable care.
AnaBioTec supports ambitious SME’s and large and established pharmaceutical companies around the world by providing analytical solutions in the areas of drug characterization, release and stability, in a GMP-certified environment.
To strengthen our ambitions, anacura in Evergem is looking for a (m/f/x):
Head QA
Function
* Play a leadership position in the quality assurance department overseeing all the activities of the quality assurance team, consisting of dedicated sub-teams per business unit; act as a mentor to the team, setting priorities, assisting in the performance of their duties and ensuring the constant improvement of their skills.
* Develop and implement strategies for the quality department to ensure compliance with applicable quality regulations and guidelines and to achieve the quality objectives of the business units; follow-up, support and actively participate in the continuous improvement of the Quality Management Systems and QA processes.
* Approve the internal audit strategy and plan and follow-up on its implementation; ensure a good preparation and organization of external audits and inspections.
* Be an escalation point for all quality matters, both internally and externally
* Define and promote a quality mindset across the entire company; collaborate with all key stakeholders in the organization to ensure the QA vision is understood and implemented correctly.
* Upon request of clients, be responsible for batch release certification of (investigational) medicinal products.
Profile
* Scientific Master’s degree (e.g. pharmacy, chemistry, biology) with minimum 10 years working experience in a QA role within the pharmaceutical industry, preferably within an analytical laboratory environment.
* Strong knowledge of GMP; experience as a Qualified Person would be favorable.
* Good technical and scientific judgment towards all areas of quality; knowledge of – or ability to familiarize quickly with – other quality systems (e.g. GLP, ISO15189, ISO13485, …), data security guidelines (ISO27001) and computer system validation requirements (GAMP5).
* Pro-active, highly interactive and collaborative professional with good problem-solving, decision-making capabilities, influencing and negotiation skills; excellent leadership, communication and organizational skills.
* Fluent in Dutch and English.
Offer
* You will be part of the anacura group, a family owned, long term focused and ambitious laboratory organization.
* You will join a dynamic team and have a position with autonomy and responsibility with opportunities to take initiatives to support further growth.
* You will be offered a competitive salary with fringe benefits, a green work environment and the possibility to join our bike lease program, flexible working hours, a healthy lunch, and a pleasant fun club.
* You are stimulated in your personal growth; we build on your talents in accordance with our ambitions.
Interested?
Your application will be considered quickly and with the greatest confidentiality. For additional information please contact Jill Colaers: jobs@anacura.com.
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