Supervisor QC Operations EM UM

GMP roles and responsibilities

• Management of EM UM sample staff and EM UM Officers including completion of performance feedback, reviews and disciplinary action.
• Ensure sampling and reporting is initiated and performed in a timely manner and adhering to quality standards.
• Draft and edit SOPs as needed.
• Responsible for insuring completion of required instrumentation maintenance and calibration.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Product Support and Production to support product release and investigations.
• Assist in the development, optimization, and validation of EM UM methods and procedures to ensure robustness, accuracy and reproducibility.
• Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key standard operating procedures such as procedures for events, out of specifications and good documentation practice and applicable ISO/EP standards.
• Review of paperwork for compliance.
• Strong understanding of trending and microbiological troubleshooting.
• Participate in continuous improvement of the department and site as a whole; record keeping, EM UM processes, site safety, etc.
• Conduct periodic work meetings with the employees of the department and hold them accountable for results.
• Resolution of technical problems in accordance with policies and procedures.
• Providing orientation and training of testing personnel.

Your profile

• Bachelor education or working knowledge at Bachelor level in the field of pharmacy, microbiology or (bio)chemistry
• >5 years of people leadership experience and performance management within a pharmaceutical QC environment
• Solid knowledge about EM UM is highly beneficial
• Strong affinity with manufacturing
• Knowledge of GMP guidelines with regard to quality control and validation
• Experienced with monthly and quarterly reporting
• Developments in the field should be followed and explored for consequences and/or usefulness for QC
• Conversational Dutch and excellent English language skills
• Ability to work fully on-site

Our offer:

• Employment for 40 hours per week (less can be discussed).
• Salary between €4700,00 and €6700,00 euro gross per month (based on full-time employment).
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• 30 holiday days
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.