Quality Engineer - Technical Operations

Prothya Biosolutions; Amsterdam; On-site; EUR 47,000 - 67,000; Full time

Benefits offered by this job

Flexible working hours

13th month

Holiday allowance

Travel allowance

Pension plan

Professional development budget

Public transport access

Parking

Job summary

Prothya Biosolutions is seeking a Quality Engineer in our Technical Operations department to support daily production activities, including deviation investigations and impact assessments on the shop floor.

You will lead root cause investigations for deviations, OOS/OOT, and contribute to continuous improvement while ensuring GxP compliance and proper documentation. A proactive, collaborative mindset is essential to drive quality across production teams.

Qualifications

• 3+ years of experience in pharmaceutical industry, preferably with sterile manufacturing.
• 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

Responsibilities

• Lead the Deviations/OOS/OOT investigation with adherence to procedures and training.
• Act as QE representative during client complaints investigations and suggest improvements.
• Support/demine training for other QE team members as needed.
• Ensure a safe, collaborative work environment and cross-functional cooperation.
• Attend production meetings and monitor for potential issues to prevent deviations.
• Provide immediate actions and coordination with QA for production quality issues.
• Contribute to GxP compliance by documenting deviations and change controls.

Skills

Root cause analysis

Quality systems

Communication

Problem solving

Teamwork

Independent work

Tools

5M methods

5x why

Is/Is not methodology

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 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 escape 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
• 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

• >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.