What will your job be
As a Specialist Laboratory Data Integrity you will be responsible for both technical and procedural requirements of Data Integrity in manufacturing and analytical environment. Further responsibilities are:
- Collaborates with Business System Owners, Technical System Owners, QA and Training to identify the most efficient action to be taken for any system and at any step of the data flowUser requirements of
(current and new) systems need to be translated into technical
- Analyses data integrity gaps and leads activities toward remediation
- Guides Business System Owners and Technical System Owners in meeting current and prepare for future expectation of Data Integrity
- Manages work according to a schedule
What are we looking for
For the position Laboratory Data Integrity we are looking for a highly motivated candidate with a bachelor or master degree in Life Sciences of Computer sciences. Furthermore you:
- Have in-depth, up-to-date knowledge of computerized systems, GxP practices and recent developments in this expertise area
- Think Independently and make decisions to find sound solutions from a structural, regulatory, and business perspective.
- Pharmaceutical or related industry work experience for 4-6 years
- You have experience in a complex, multinational work environment.
- Work experience within the field of computerized systems quality / validation is preferred.
What do we offer
- A contract for 12 months at CheckMark
- Salary indication starting at €3627gross per month based on a full-time position
- Full-time position (40 hours.week) with 32 hoursnegotiable
Where will you work
A large biopharmaceutical company. You will work within the site Data Integrity Team, specifically focusing on manufacturing and analytical systems linked to Covid-19 Vaccine production. Performs and analyses data integrity gap assessments and proposes remediations (technical, procedural, trainings), coordinating activities and stakeholders to lead to full gap remediation. Offers guidance and support to the business to improve GxP processes related to DI topics such as Security / User Access Management, Audit Trail Review, Backup & Archival.