QA Expert Validation (f/m/d)
Apply now »Date: Mar 13, 2023
Location: Amsterdam, NH, NL
Company: Wacker Chemie AG

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).
Reference Code: 21464