Vacature QA Officer Operations – Validation, Amsterdam
Sanquin Bloedvoorziening voorziet in de behoefte aan bloed en bloedproducten in Nederland. In feite staan wij tussen donor en patiënt. Om deze verantwoordelijke taak goed te kunnen blijven vervullen, zijn we altijd op zoek naar betrokken en gemotiveerd talent. Je zal bijdragen aan een unieke organisatie die een internationale voortrekkersrol vervult dankzij de combinatie van medische, farmaceutische en wetenschappelijke kennis in één innovatieve onderneming. Sanquin Bloedvoorziening is op zoek naar een:
QA Officer Operations # Validation, Amsterdam
FL13-14 EXTEW eng
Challenging QA function with emphasis on multifaceted validation tasks and responsibilities!
Within the international team of the QA Operations Department there are opportunities for candidates who will help build a professional organisation and who will act as a sparring partner for all our internal and external international partners and customers. As a QA Officer at Sanquin you will perform a wide range of challenging tasks. For the current vacancy the focus is primarily in the field of validation of manufacturing processes, the equipment and IT systems used for that purpose, and the validation of logistic processes (cold chain). As we are looking for multiple experts, you do not have to control all of these fields, we are aiming to ensure that the final team has all the expertise required. It is the QA Officer#s task to apply the guidelines and procedures and hereby advise the customers. As a QA Officer you will often be in the factory. You are involved in reviewing validation protocols and reports, associated procedures, supporting and reviewing change control documentation, the reviewing of batch records. You will also be involved in researching and reporting defects as a result of OOS, deviations and customer complaints.
We also have opportunities for Senior QA Officers. In the Senior QA Officer position you will participate, in addition to the activities mentioned above, in cross-functional international teams to establish and roll out a clear validation policy within Sanquin. You have an active role in the drafting of policies, Validation Master Plans, templates, and you will train/coach your colleagues in these. You may also be expected to set up and/or perform proactive (improvement) actions in response to changing guidelines, audits, deviations.
For both the QA Officer and the Senior QA Officer it applies that your input for both project teams and within the Department itself contributes to promoting quality awareness. In short: a very diverse QA position, in which you can improve your love for quality.
Sanquin Plasma Products in Amsterdam is a rapidly growing division of the stichting Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation). The division produces a wide range of high quality (bio) pharmaceutical medicines from human plasma. The complex manufacturing process (plasma fractionation) is handled by approximately 300 professionals in the modern factory, in accordance with GMP guidelines. 60 professionals work within the QA Department on behalf of Operations, of which 50% work in QA Systems and 50% work in QA Operations. The QA Operations Department consists of three sub-Departments that are characterised by a pleasant, open atmosphere, where collaboration is a high priority. These sub-Departments are linked to the different parts of the production process. This process consists of a long series of carefully controlled steps, with which coagulation factors, protease inhibitors, immunoglobulin and albumin are produced. The QA Operations Fractionation sub-Department advises and supports the same production Department on defects, changes, deviations and other relevant quality issues. The activities of the Fractionation Department concern the process steps in which the various blood products are isolated and purified from plasma. Sanquin Plasma Products is currently also involved in the development and growth to the position of Contract Manufacturing Organisation (CMO) for this Fractionation process, which is increasing the demand for more and different QA support. Sanquin is therefore searching for additional QA Officers at various levels, in order to bring the production quality to the next level.
We are looking for:
- completed higher business education (HBO);
- at least 2 years experience with validation activities, preferably in the (bio) pharmaceutical industry;
- knowledge of cGMP guidelines and experience with the latest FDA guidelines is required;
- perseverance, good team worker, customer-focused and good communication skills;
- strong relationship building skills, advising and persuading;
- excellent knowledge of English both spoken and written (knowledge of Dutch is not obliged).
- help develop the further professionalization of the QA Department;
- state of the art (bio) pharmaceutical manufacturing plant;
- work with high quality biotechnology products;
- ample development prospects;
- a 36-hour-week
- working hours will be determined by mutual agreement;
- reimbursement of travel expenses in accordance with CAO;
- 8,33% year-end;
- 201 vacation hours with time employment.
For information regarding this vacancy, please contact Mrs. E. Titulaer, Manager QA Operations, phone number 020-5127098.
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