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We are looking for a Quality Assurance Associate to join the dynamic team of a consulting company passionate about offering solutions in medical, regulatory affairs and quality assurance projects for pharmaceutical and healthcare industry. All projects are worked on in close cooperation with one or more colleagues and for some projects, the Quality Assurance Associate also works on site at the clients’ office for 1 or 2 days per week.
Skills and personality
As a QA Associate, you will support the Responsible Person in setting up, improving and maintaining quality standards for pharmaceutical and healthcare companies in BeNeLux.
- Establish and maintain a quality system: SOP Management, change control, training, deviations, CAPA, etc.
- Review packaging specifications and technical changes in preparation of administrative batch release
- Coordinate the reporting of product quality complaints
- Perform GDP self-inspection and assist in external audits
- Draft, implement and monitor quality agreements
- Interact with regulatory department, suppliers and contract manufacturing organizations
- Cooperate with the QA department of the clients other EU affiliates
- Support the Responsible Person in all quality related aspects
- Participate in quality related audits or inspections from health authorities
- Stay up-to-date with the latest developments and relevant legislation
- Level of education: Master’s degree in life sciences
- Experience: a first experience with QA/a Quality Management System
- Familiar with good documentation practice and project management
- Good communication skills in Dutch, French, English (both written and verbal)
- Proficient with computer and Microsoft Office
- Strong initiative and problem solver
- Experience with GDP, pharmacovigilance and/or regulatory affairs
- Detail-oriented: concern for quality, compliance and consistency
- Good communicator and team player
minimum 3 years
Dutch, English, French
Submit your CV
Please submit your CV through the form below and we will contact you shortly.