Senior Quality Control Officer - Environmental Monitor…

Senior Quality Control Officer – Environmental Monitoring

As a Senior Quality Control (QC) Officer – Environmental Monitoring, you are responsible for overseeing and executing environmental monitoring activities within controlled manufacturing areas to ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal quality standards. Your role involves advanced data analysis, troubleshooting, and mentoring junior staff, ensuring that environmental control programs are robust and effective.

Key Responsibilities:

Environmental Monitoring Program Management

• Perform and oversee routine environmental monitoring (air, surfaces, personnel) in classified areas.
• Ensure sampling plans comply with regulatory guidelines (EU GMP Annex 1, FDA, ISO standards).
• Review and approve monitoring schedules, sampling locations, and risk assessments.

Data Analysis & Reporting

• Analyze environmental monitoring data for trends and deviations.
• Prepare detailed reports and summaries for internal audits and regulatory inspections.
• Implement corrective and preventive actions (CAPA) based on data trends.

Compliance & Documentation

• Maintain accurate and complete documentation in accordance with GMP and company SOPs.
• Support investigations related to environmental excursions and contamination events.
• Ensure compliance with regulatory requirements during audits and inspections.

Continuous Improvement

• Identify opportunities for process optimization and contamination control.
• Participate in validation activities for cleanrooms and controlled environments.
• Contribute to risk assessments and contamination control strategies.

Leadership & Training

• Mentor and train junior QC staff on environmental monitoring techniques and GMP compliance.
• Act as a subject matter expert (SME) for environmental monitoring during audits and cross-functional meetings.

Your profile:

• Bachelor’s degree in Microbiology, Biotechnology, or related life sciences field (Master’s preferred).
• Minimum 5 years of experience in QC environmental monitoring within the pharmaceutical or biotech industry.
• Strong knowledge of GMP, EU Annex 1, ISO cleanroom standards, and regulatory guidelines.
• Experience with EM data review and writing EM reports.
• Proficient in data trending, root cause analysis, and CAPA management.
• Excellent communication, leadership, and problem-solving skills.
• Familiarity with electronic data systems (MODA, SAP or other comparable LIMS systems) and aseptic techniques.
• Attention to detail and accuracy.
• Ability to work independently and lead a team.
• Strong analytical and organizational skills.
• Commitment to quality and continuous improvement.
• Fluency in English. A conversational level of Dutch is preferred.

What do we offer?

• Full-time employment (40h) with flexible working hours in consultation. Working part-time 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.

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.