Functietitel: Data Integrity Officer

Functieomschrijving:
For our client we are looking for a Data Integrity Officer. - You are responsible for departmental data integrity practices and procedures as well as chairs the Data Integrity Governance Meetings. - You ensure all new and existing equipment is assessed appropriately and validated for its intended use and existence, usage and review of audit trails. - You are responsible for providing gap assessments and status updates to aid Data Integrity Governance teams actions to maintain and improve data integrity. - You will perform risk assessments to determine high risk equipment and audit trails and take appropriate action. - You will provide quarterly training to all lab operations to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practices. - You own, create and update procedures as necessary to ensure laboratory operations, data integrity awareness, accountabilities, responsibilities and the importance of corporate and regulatory requirements and expectations are proceduralized. - You will create and execute Change Controls for laboratory instrumentation. Establishes user requirements for laboratory equipment. - You will ensure all software brought into the laboratory for the generation of cGMP data meets the standards in regards to Part 11 compliance. - You will audit QC-lab and analysts for compliance to establish documentation and data integrity standards, practices and procedures. - You advices audit trail reviewers staff to ensure the efficient operation of the function. Works with and advises staff on administrative policies and procedures. Provides feedback to personnel and management upon. Een verantwoordelijke functie bij een grote organisatie. De functie biedt uitzicht op vast dienstverband. Het salaris is afhankelijk van werkervaring en opleiding. Heb je naar aanleiding van deze functie nog vragen? Neem dan contact op met Jolijn van Berkel via...

Uren per week: 40-40

Werkgever Naam: Balans Laboratorium

Vorm van contact: Jolijn van Berkel

Werkgever telefoonnummer: 088-8900801

Job korte beschrijving:
Vakspecialisten op statistisch en wiskundig gebied e.d.

Land: Nederland

Regio: NEDERLAND

Contractduur: Vast

Contract type: Voltijds

Ervaring: Tussen 2 en 5 jaar

Bron van jobaanbieding:
UWV WERKbedrijf, Openbare diensten voor arbeidsvoorziening, Nederland

Rijbewijs: Nee

Salaris munt: EUR