Join a leading organization in the pharmaceutical sector where your expertise will enhance product development initiatives. Our client is seeking a dedicated professional to ensure compliance and quality standards are met in a challenging and impactful environment.
As an ideal candidate, you are a skilled
compliance engineer
with a strong background in automation or data integrity. Your attention to detail and commitment to quality will be essential in this role.
* You execute qualification activities for all equipment in the plants, ensuring standards are upheld.
* You are the specialist owner of qualifications in multidisciplinary projects.
* You develop, execute, and report on qualification protocols that comply with GMP guidelines.
* You write URS, manage risk assessments, and create various qualification protocols (PQP, DQ, IQ, OQ, PQ).
* You conduct functional tests and create reports based on your findings during fieldwork.
* You document quality incidents, deviations, and follow up on corrective actions as per protocols.
* You participate in continuous improvement initiatives and manage CAPAs within the system.
What are we looking for?
* You hold a
Master's degree in a technical field
or equivalent experience.
* You have
5-10 years of experience
in qualification activities within the pharmaceutical sector.
* You are experienced in writing qualification documentation and executing protocols.
* You have a good understanding of GMP and GDP regulations.
* You possess knowledge of safety documentation related to change control as a plus.
* You demonstrate strong problem-solving and analytical skills.
* You work independently and in a planned manner.
* You are fluent in
Dutch
and
English
, both spoken and written.
* You have a solid command of
Microsoft Office
applications (Excel, Word).