As a Senior Quality Engineer you play a crucial role within our Technical Operations department. This position demands a high level of expertise and knowledge regarding products and production processes to handle complex records, including events, deviations, out-of-specifications/out-of-trend (OOS/OOT), and complaints, necessitating in-depth investigation.
Key accountabilities:
Complex investigation leader
- Lead in-depth investigations into complex deviations, ensuring collaboration with relevant deparments to achieve accurate resolutions right-first-time.
- Capable to do a Process Assessment when defining CAPAs
- Conduct Product Impact Assessments to evaluate potential quality and safety implications.
Ensure production continuity
- Maintain production continuity by addressing complex technical, process, and material issues.
- Conduct Gemba walks on the shop floor to observe and analyze production processes firsthand.
Participation and management of improvements
- Manage Corrective and Preventive Actions (CAPAs).
- Detect and implement efficiency improvements using 6 sigma methodology in order to prevent deviations and process-related issues
- Engage in regular trend analysis to identify root causes of issues within various departments.
- Coordinate with your Supervisor to organize and conduct meetings focusing on recurring issues within the department.
Support to the QE team
- Serve as a backup to your Supervisor as needed.
- Mentor and provide guidance to Quality Engineer staff.
GxP
Has a broad and in depth understanding of existing and emerging regulatory GxP requirements within own field of expertise. Decision maker with regards to GxP (e.g. decisions on strategy to adapt in case of process related issues). Manages GxP deviations and follows mandatory GxP training and maintains an appropriate training record.
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.
- >5 years of experience in a comparable role as a technical Quality Engineer within the pharmaceutical sector, demonstrating a successful history of leading complex investigations and enacting meaningful quality enhancements.
- Deep understanding of pharmaceutical production processes, current Good Manufacturing Practices (cGMP), and Quality systems.
- Technical proficiency in the manufacturing process, equipment, and products
- Skilled in risk analysis tools and methodologies, data analysis, and engineering principles.
- Excellent communication skills, both written and verbal
- Strong leadership capabilities
- Proactive approach to problem-solving
What We Offer
- Full-time employment with flexible working hours in consultation (working part-time can be discussed)
- A salary between € 4.702,26 and € 6.759,41 gross per month (based on full-time employment)
- A budget of 16,66% (holiday allowance and 13th month) on top of your gross salary, yours to spend or to save monthly
- 30 holiday days (based on fte)
- 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.