QA - QA Expert Systems & Compliance

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Based in Amsterdam, this full-time QA Expert Systems & Compliance role focuses on Qualification and Validation, reviewing qualification documents and coordinating QA activities to enable final releases of equipment and systems. You will act as a QA delegate in multidisciplinary projects, review protocols and reports, and participate in GMP audits and deviation investigations. Requirements include a bachelor in Analytical Chemistry, Microbiology, Biochemistry or Pharmaceutical Sciences, at least 3 years in pharma equipment qualification, the ability to work under tight deadlines, MS Office skills with Veeva and SAP a plus, and fluent Dutch and English; eligible to work in the Netherlands. We offer a competitive package, 30 vacation days, flexible hours and development via GoodHabitz. To apply, tailor your CV to highlight QA documentation review, qualification and validation experience, audits, include Reference 31168, and confirm onsite availability in Amsterdam.

Are you looking for a new challenge? For our location Amsterdam we are looking for a QA - QA Expert Systems & Compliance.

The QA Expert Systems & Compliance (Focus: Qualification/Validation) reviews qualification/validation documents and coordinates and conducts QA activities.

Job responsibilities

• Reviews and approves qualification and validation documents in order to prepare the final QA release of equipment, systems, processes and computer systems;

• Ensures, in cooperation with the responsible employees that errors in the documentation are corrected;

• Participates as a QA delegate in multidisciplinary project groups for the purchase, qualification and (re)validation of equipment, systems, processes and computerized systems;

• Reviews protocols, reports, test documents and other relevant documents in order to facilitate the final QA release of equipment, systems, processes and computerized systems;

• Register, calculate, check and assess data as needed to review relevant documentation;

• Participates in research and corrective actions related to quality issues at the request of QA management;

• Carries out spot audits and formulates the follow-up in collaboration with the relevant departments;

• Participates in external GMP audits and inspections of supply companies, customers and government agencies;

• Investigates reported deviations after a quality issue within production or QC. Coordinates follow-up;

• Assists in the preparation of annual reports and provides statistical overviews of the release data for the actual release;

• Participates in special interdisciplinary task forces where QA input is desired;

• Supports QA management with regard to all developments in the field of quality, GMP and legal guidelines and plays an important role in further and wider integration of quality

in the company.

Qualifications Required

• Minimum Bachelor degree in the orientation of Analytical Chemistry, (Micro)Biology, Biochemistry or Pharmaceutical Sciences;

• A minimum of 3 years experience in the pharmaceutical industry in the field of equipment qualification and related topics;

• Ability to work with tight deadlines and handle multiple tasks;

• Computer fluency in MS Office, e.g. Word, Excel, PowerPoint. Knowledge of Veeva and SAP is a plus;

• Experience with FDA compliance is a plus;

• Profound knowledge of Dutch and English language, verbal and written;

• You reside in and are eligible to work in The Netherlands (valid work permit).

What do we offer?

• Employment: A challenging and international position in a professional and informal working environment
• Compensation: Attractive salary, holiday allowance, home-office travel allowance, participation in the company's success, subsidized pension plan
• Work-life balance: Flexible working hours (where possible), 30 days of vacation
• Versatile development opportunities: Support for professional development, access to online learning platform GoodHabitz

As an international company, we welcome the diversity of people. We consciously promote equal opportunities and a diverse, inclusive culture in our teams - this is what makes us successful.

We look forward to receiving your application!

Reference Code: 31168