QA Expert Validation (f/m/d)

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Date: Mar 13, 2023

Location: Amsterdam, NH, NL

Company: Wacker Chemie AG

Our world needs ideas! As one of the world’s most research-intensive chemical companies, we have been developing leading solutions for numerous sectors – from construction to photovoltaics and cosmetics to rubber – for over 100 years. We have a global presence with production sites on three continents and about 14,500 employees from 70 nations.
Wacker Biotech, as part of WACKER, is a leading global biotechnology organization specializing in the production of biopharmaceuticals. The company has outstanding technologies for the rapid, efficient and thus cost-effective production of therapeutic proteins for clinical and commercial supply. Currently it is the biggest dedicated microbial Contract Development & Manufacturing Organization (CDMO) in the world. Its four dedicated and fast-growing production sites are currently based in Germany (Halle and Jena), The Netherlands (Amsterdam) and The United States (San Diego, CA).
Are you looking for a dynamic, globally active technology company – yet at the same time, you appreciate a value-oriented, trusting company? We offer you exciting work as part of a team of experts who treat each other as equals. At our Amsterdam-based center Wacker Biotech B.V. focuses on the GMP-compliant microbial based production of recombinant proteins, vaccines and live microbials as drug substance and drug product.

We are currently looking for a ​QA Expert Validation (f/m/d)​ to join our growing team.

For more detailed information please feel free to contact Mrs. Peggy Engels, tel. 0031 (0)20 7503 675.
Please note: Agency acquisition to this vacancy is not appreciated. 

Job responsibilities:

The 'Quality Assurance Expert Validation' is responsible for keeping the Quality oversight with regards to Engineering and Validation matters. He/she distinguishes from the rest of the QA Experts by his/her expertise in Validation and in particular in Computerized System Validation. The responsibilities of the QA Expert Validation include:

  • Review and approval of validation documents, including but not limited to risk assessments, project plans, protocols and reports;
  • Quality oversight of all Qualification, Validation and Engineering activities;
  • Active participation in project teams for the implementation or modification of equipment, systems and buildings;
  • Handling and assessment of deviations and change controls related to his/her expertise;
  • Assessment of Building Monitoring System alarms and trends;
  • Participation in client audits and regulatory inspections as SME;
  • To take a leading and advisory role in CSV matters;
  • Execution of internal audits according to audit plan;
  • To assure Quality compliance with the current regulations and guidelines applicable to his/her area of expertise;
  • To address  GMP deficiencies and propose improvements in his/her area of expertise Qualifications required.


Qualifications required:

  • A minimum of education of HBO level in the orientation of Chemistry, (Micro)Biology, Physics, Engineering or Pharmaceutical Sciences;
  • A minimum of 4 years experience in the pharmaceutical industry, preferably in Quality Assurance;
  • Solid knowledge of applicable regulations and guidelines;
  • Excellent verbal and written communication skills;
  • Ability to work with tight deadlines and handle multiple tasks;
  • Computer fluency in MS Office. Knowledge of Veeva 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).
WACKER, as an innovative chemical company, makes a vital contribution toward improving the quality of life around the world by developing intelligent solutions for sustainable growth. Our culture focuses on building and retaining diverse and inclusive teams. WACKER offers a great work environment, professional development, challenging careers, competitive benefit offerings and beyond through giving back to our communities.
Be part of our WACKER family. Across all nations.
We are looking forward to your online application at 
Reference Code: 21464