Join a cutting-edge team dedicated to ensuring the highest standards in computerized systems validation (CSV) within the regulatory framework. This is an exceptional opportunity for a motivated professional to make a significant impact in the pharmaceutical industry.
As an ideal candidate, you are a skilled QA CSV Engineer prepared to tackle complex challenges in a dynamic environment. You thrive in cross-functional teams and possess a keen understanding of regulatory requirements.
You assure that all CSV related regulatory requirements are fulfilled throughout the complete life cycle of computerized systems.
You review trends within the CSV area and initiate actions for improvements.
You act as a mediator among various groups regarding CSV matters.
You maintain the Validation Master Plans and ensure timely execution of validation activities.
You review and approve CSV documents to ensure compliance with regulations and organizational standards.
You participate in the introduction of new systems and processes, providing valuable advice on CSV-related activities.
You prepare for audits and inspections, acting as the spokesperson for CSV during these evaluations.
What are we looking for?
You have a university degree or similar qualification.
You possess at least 3 years of experience in a similar role.
You have expertise in cGMPs, specifically 21CFR11, 21CFR210, and related guidelines.
You bring strong problem-solving skills to address challenging situations.
You are an excellent communicator, capable of conveying technical information at all levels of the organization.
You are proficient in English and Dutch.
You have specific knowledge of Quality Management Systems and IT systems used in pharmaceutical manufacturing.
You hold familiarity with Deviation and Change Management Systems.
You have experience with Test Tools like qTest and KNEAT.