Quality Engineer - Technical Operations

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.

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

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.