Join a dynamic project team dedicated to upholding the highest standards of quality and compliance within the pharmaceutical industry. We seek a motivated professional eager to contribute to our mission of ensuring rigorous quality in every aspect of the commissioning, qualification, and validation processes.
As the ideal candidate, you are a skilled
QA Engineer
with significant experience in mechanical quality assurance and validation, passionate about ensuring compliance with stringent industry standards. If you are detail-oriented and dedicated to quality, this role is perfect for you.
Tasks
* You participate in validation risk assessments and provide quality input throughout project phases (Design, Commissioning, IOQ, PQ).
* You review and approve commissioning and qualification protocols, test scripts, and reports for manufacturing equipment and computerized systems.
* You verify that qualification activities are performed according to established procedures and regulatory requirements.
* You provide quality oversight during the execution of qualification activities.
* You review and approve change controls and other quality documentation related to CQV activities.
* You work closely with various teams including Commissioning, Qualification/Validation, Engineering, Manufacturing, and Technical Services.
* You provide quality guidance to stakeholders on validation requirements.
What are we looking for?
* You hold at least a
Bachelor's degree
in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related scientific/technical field.
* You have a minimum of
3 years of experience
in the pharmaceutical/biotech industry, focusing on CQV activities.
* Additional qualifications in Quality Assurance or Validation are a plus.
* You have demonstrated knowledge of qualification and validation principles.
* You possess experience with GMP manufacturing environments.
* You have a thorough understanding of EU GMP, FDA regulations, and ICH guidelines.
* You have
excellent communication skills
for effective collaboration with project teams.
* You are detail-oriented with a focus on assuring high-quality projects.
* You exhibit strong problem-solving abilities and the capacity to make decisions in dynamic project environments.
* You have multilingual proficiency for effective communication in diverse engineering contexts (English and Dutch).
* You have strong interpersonal skills and the ability to work in cross-functional teams.
* You are capable of managing multiple priorities and meeting deadlines.