Senior Quality Engineer - Technical Operations

Prothya Biosolutions; Amsterdam; Presencial; EUR 52.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible hours

Full-time

Holiday allowance

13th month

Training budget

Travel allowance

Public transport access

Private parking

Pension plan

Descripción de la vacante

Prothya Biosolutions in Amsterdam seeks a Senior Quality Engineer to lead complex investigations and drive quality enhancements within our Technical Operations. You will manage CAPAs, perform risk-based assessments, and ensure compliance with cGMP and GxP requirements.

You will mentor QE staff, collaborate across departments, and contribute to a culture of continuous improvement while supporting production continuity and patient safety.

Formación

• 5 years of experience in a comparable role as a technical Quality Engineer within the pharmaceutical sector.
• Deep understanding of pharmaceutical production processes, cGMP, and Quality systems.
• Technical proficiency in manufacturing processes, equipment, and products.
• Skilled in risk analysis tools, data analysis and engineering principles.
• Excellent written and verbal communication and strong leadership.
• Proactive problem-solving approach.

Responsabilidades

• Lead in-depth investigations into complex deviations, ensuring cross-department collaboration to achieve right-first-time resolutions.
• Perform Process Assessments when defining CAPAs and conduct Product Impact Assessments for quality and safety implications.
• Maintain production continuity by addressing complex technical, process, and material issues.
• Conduct Gemba walks to observe and analyze processes on the shop floor.

Descripción del empleo

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.
• 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:

• 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.