(Senior) QA Officer - Utrecht
|Publication date:||November 20 2020|
|Employment type: ||Permanent|
|Function Group: ||Quality/RA|
Functiegroepen: Quality/RA / QA Officer
For a fast-growing biotech company we are looking for a (Senior) QA Officer. The organisation is focused on building comprehensive living biobanks of characterised organoids and developing assays for drug screening and validation.
The (Senior) QA Officer supports service contracts and research projects, commissioned predominantly by pharmaceutical companies. This position allows you to drive the development of a state-of-the-art quality management system (QMS) with the aim to achieve ISO certification and/or accreditation in the near future to support preclinical services and future in vitro diagnostic medical device (IVD) development of organoids. You will report directly to the QA Manager, and will work together in close liaison with technicians, researchers and regulatory affairs’ colleagues. You will interact with external parties such as the notified body and other external auditors, as well as represent the company at relevant meetings. A successful candidate ensures the implementation of QMS in the context of the project quality in control to support the growth of the organisation.
As (Senior) QA Officer you will be responsible for:
- Driving development of the QMS
- Ensuring compliance to requirements defined in the QMS
- Writing QA documentation such as SOPs
- Assisting the research team in the compilation of technical documentation for IVDs to be applied in a medical laboratory
- Acting as facilitator for associated risk assessments according to ISO 14971
- Organising and conducting internal audits as lead auditor
- Creating in-depth training context regarding applicable laws and regulations for internal use and training its employees
- Ensuring employee awareness of individual and collective contribution to QA compliance
- Suitable candidates have a Master, preferably in the field of life sciences or a comparable area, followed by a minimum of 3-5 years of relevant work experience in a commercial, ISO-certified or GMP environment
- Ideally, you have gained experience in maintaining a flexible and sustainable QMS, including compliance to laws and regulations related to the design and development, manufacturing and quality control of IVDs
- Experience with the establishment of a technical dossier for an IVD according to the EU IVD directive 98/79/EC and/or EU IVD Regulation 2017/746
- Experience in implementing requirements of ISO 13485
- Experience with writing and reviewing standard operating procedures
- Strong written and oral skills in English and preferably Dutch
- Excellent communications and collaboration skills round off your profile
What is on offer?
- A high paced, professional and international environment
- Genuinely meaningful work as part of a company with unwavering commitment to apply organoid technology globally for the benefit of the patients
- Generous annual leave of 30,5 days (FT) plus national holidays
- Pension plan with 2/3 contribution
- Healthy work-life balance with flexible working hours
- International work environment in a multi-cultural team
- Opportunity to grow in this position alongside the promising organisations development
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Principal Consultant | Biotech & Pharma