Supervisor QC Operations EM UM

Prothya Biosolutions; Amsterdam; On-site; EUR 60,000 - 75,000; Full time

Benefits offered by this job

8.33% end-of-year bonus

€2,100 personal training budget every three years

Contribution to travel expenses

Pension plan with Zorg & Welzijn

Excellent accessibility by public transport

Job summary

A leading pharmaceutical firm in the Netherlands seeks a Supervisor QC Operations EM UM to manage environmental sampling processes. This role involves overseeing staff, ensuring compliance to GMP guidelines, and improving quality control methods. Candidates must have a Bachelor's degree in a related field, strong leadership skills, and fluency in Dutch and English. The offer includes a 40-hour work week, bonuses, a personal training budget, and a pension plan, promoting a dynamic work environment.

Qualifications

• 5+ years of experience within EM, with at least 3 years of people leadership experience.
• Conversational Dutch and excellent English language skills.
• Experienced with monthly and quarterly reporting.

Responsibilities

• Manage EM UM sample staff and ensure compliance with quality standards.
• Draft and edit SOPs as needed.
• Collaboration with cross-functional teams for product release.
• Conduct orientation and training of testing personnel.

Skills

People leadership

Quality control

Microbiological troubleshooting

GMP guidelines knowledge

Reporting skills

Collaboration

Education

Bachelor's degree in pharmacy, microbiology or (bio)chemistry

Job description

As our Supervisor QC Operations EM UM you are responsible for environmental and utility sampling and reporting and you will play a critical role in ensuring compliance of the utilities and environment in the manufacturing of pharmaceutical products.

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.
• Take 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 experience within EM among which at least 3 years of people leadership experience and performance management
• Experienced with monthly and quarterly reporting
• Strong affinity with manufacturing
• Knowledge of GMP guidelines with regard to quality control and validation
• Developments in the field should be followed and explored for consequences and/or usefulness for QC
• Conversational Dutch and excellent English language skills.

Our offer:

• Employment for 40 hours per week (less can be discussed).
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• 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.