Quality Assurance Systems Officer

Your responsibilities are:

·       Quality system documentation: Keeps track of upcoming and ongoing mutations in quality system documentation. Reviews documents, procedures and instructions and ensures they comply with standards. Optimizes the effectiveness of the documentation.

·       Research results: Directs quality research (batch- and non-batch-related), checks products, services and related reports and analyses the cause of deviations. In cooperation with process owners, assesses the impact of (complex) deviations and oversees their handling. Delivers reports to support decision-making.

·       Quality risk management coordination, being responsible for the maintenance of the compliance risk register.

·       Audit results: Prepares external audits, including by providing the necessary documentation and facilitates their execution. Leads and conducts internal audits. Oversees timely and adequate handling of observations and providing management reporting.

·       Use of applications for the quality system: Identifies improvement opportunities regarding the applications for the quality system. Assists with innovations in the applications, e.g. by providing training.

·       Follows internal and external developments in the field of quality management and changes in legislation and regulations.

·       Advice and process support: knowledge of the quality system (structure, systematics, relations with other quality system components).

·       Training: ensuring in coordination with the Global Lead Training that the training system in place is compliant to GMP requirements and aligned to the organization needs. Ensuring that the training process is implemented uniformly and coordinated for the entire organization, as well as making sure that all departments comply with general training procedures. 

Your profile

·       Bachelor’s degree in Chemistry, Pharmacy, Biology or related.

·       You have min 3-5 years of experience within a similar role (Quality experience is a must, pharmaceutical sector is an advantage);

·       You are familiar with working in a regulated environment;

·       You are fluent in English writing and oral skills;

·       You preferably also have knowledge of Dutch and/or French;

·       You have excellent communication skills;

·       You have experience in the subjects as mentioned above;

·       You have a pragmatic spirit and you are solutions and quality oriented.

·       You are comfortable working and dealing with IT tools.

Our Offer

We offer you a full-time job and a one-year contract to begin with. The following employment conditions apply:

·       Full-time employment

·       8.33% end of year bonus and 8.33% holiday allowance

·       Flexible working hours in consultation

·       Personal training budget of €2,000 per 3 years

·       Contribution to travel expenses from the first kilometer

·       Good accessibility by public transport and private parking

·       Pension plan at Zorg & Welzijn.

Learn More

If you want to know more about this vacancy, please contact our recruitment department via careers.nl@prothya.com. Do you recognize yourself in the profile and do you want to take on this challenge at Prothya Biosolutions? Then we would like to receive your CV and motivation via the apply button on this page. We aim to give you a response back within a week.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.