Quality Engineer  Amsterdam • Prothya Biosolutions

Your responsibilities:

1.     Deviations/OOS/OOT investigation

• Lead the investigation using the relevant procedures and training for root cause analysis
• Propose corrective and preventive actions
• Assess the impact on the product, with support from other departments or SMEs if needed

2.     Ensure production continuity

• Ensure a minimal presence of QE on the shopfloor to prevent deviations and enhance the quality culture on the shopfloor
• Be actively part of the daily follow-up of production operations, by attending daily production meetings and escalate potential new issues
• Act as the primary point of contact in case of production quality issues, and advise on the immediate actions to be taken in coordination with QA

3.     Complaints investigation

• Act as the representative of production during investigation upon complaints coming from the client

4.     Ensure continuous improvement

• Propose short-term improvements for the production areas, processes, procedures to ensure continuous improvement within the production departments
• Participate in improvement-orientated meetings and workshop to ensure continuous improvement on root-cause analysis and investigation methodology within Prothya

5.     Support to the QE team

• If applicable, upon decision of the supervisor, mentor new Quality Engineer by providing the on-the-job trainings for events, deviations and OOS-OOT.

6.     Reporting 

7.     Leadership

• Ensures a safe, secure, and healthy work environment.
• Ensures collaboration within the team and other departments.

GxP

Has understanding of existing regulatory GxP requirements (within area of own expertise). Interacts cross functionally to ensure GxP compliance and writes SOPs. Follows mandatory GxP training and maintains an appropriate training record. Writes GxP documentation such as deviations and change control records.

Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key SOPs such as procedures for Events, OOS and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues.

Your profile:

• Bachelor’s degree in a relevant discipline.
• >3 years of experience in pharmaceutical industry, preferably with sterile manufacturing, demonstrating the ability to use investigation tools
• Deep understanding of pharmaceutical production processes, current Good Manufacturing Practices (cGMP), and Quality systems.
• Preferably skilled in root cause analysis tools (5M, 5x why, Is/Is not methodology…)
• Excellent communication skills, both written and verbal
• Proactive approach to problem-solving
• Strong team working mindset and ability to work independently

What 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.