QA Expert Validation (f/m/d)

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).