Key Skills

Job Description

As a Quality Engineer in our Technical Operations department you support production activities on a daily basis by performing different activities such as deviation/OOS-OOT investigations and impact assessment, presence on the shopfloor, advising upon deviation from procedures during the process. 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 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 Complaints investigation Act as the representative of production during investigation upon complaints coming from the client 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 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. 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 do we offer? Full-time employment (40h) with flexible working hours in consultation. Working part-time (32h or 36h) is possible as well. Salary between € 4.179,77 and € 6.008,42 euro gross per month based on full-time employment. 8.33% holiday allowance and 8.33% end-of-year payment (13th month). 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.

Core Responsibilities

Lead investigations into deviations, OOS/OOT events, and customer complaints; assess product impact, recommend corrective and preventive actions, and support production continuity. Maintain a visible shop-floor presence, advise on production quality issues, contribute to continuous improvement, and support GxP compliance and team development.

Requirements

Requires a bachelor’s degree in a relevant discipline and more than three years of pharmaceutical industry experience, preferably in sterile manufacturing. Candidates should understand pharmaceutical production, cGMP, and quality systems, and bring investigation skills, strong communication, proactive problem-solving, and the ability to work independently and collaboratively.

Benefits

• Flexible Working Hours
• Part-Time Work Option
• Holiday Allowance
• Year-End Payment
• 30 Days Of Holiday
• Personal Training Budget
• Travel Expense Contribution
• Public Transport Accessibility
• Private Parking
• Pension Plan
• Professional Growth Opportunities