For our client - a renowned biotech company in Brussels, Belgium - I am looking for a Quality Engineer - QC Improvement!
As an Engineer - QC Improvement, you are responsible for safeguarding the smooth running of the various processes within the department. Using Lean methodology, you will optimise the processes, together with the implementers, so that "flow" is guaranteed and the processes are "First Time Right" with a minimum of "waste". If there are quality deviations in the lab that require more detailed investigation, you will be responsible for using problem-solving methodology to manage and report on this investigation. All of this must comply with the GMP quality system used. By doing this, you continuously improve the QC processes and do your part to ensure that the quality of the pharmaceutical products made meet the European and American cGMP guidelines.
Key responsibilities and result areas:
- You are responsible for the safeguarding the processes within QC. You uncover and expose bottle necks, propose improvements together with the team, and then implement and follow up the result. This is done in compliance with the applicable regulations.
- In the event of deviations, you support the lab staff in their investigations. If the investigations are complex because the root cause is not obvious, you take the lead in the investigation. You use problem-solving methodology and document your processes according to the quality guidelines in the quality monitoring system. To this end, you work closely with the quality department.
- If the defined improvements resulting from the two points above require it and/or if Management requests it, you will:
- create or adapt department-specific procedures and/or work instructions.
- initiate change control as well as its implementation and follow-up.
- Initiate CAPAs (Corrective Action / Preventive Action) as well as their implementation and follow-up.
- prepare and follow up on (monitoring) reports.
- Create periodic trending reports.
- Visualise processes (Andon).
- Investigate improvement proposals from employees, provide feedback and implement them, where appropriate.
- Participate in internal and external audits and inspections.
- You are responsible for supporting employees in the continuous improvement of our processes, in terms of both efficiency and quality.
- You have a Master’s degree (preferably in: Chemistry, Industrial Pharmacy or Biotechnology), and a department-specific interest or affinity is required.
- You have at least 2 years of experience in a similar position in the pharmaceutical or food sector.
- Knowledge of quality systems is a requirement; experience with European and American GMP (Good Manufacturing Practices) guidelines and SOPs (Standard Operating Procedures) is a plus point.
- You work efficiently with the MS Office package; knowledge of SAP/MasterControl is a plus point.
- You have knowledge of and experience with Lean Management (e.g. Six Sigma, Value Stream Mapping, Andon, 5S, Gemba etc.).
- Fluency in Dutch and basic knowledge of French (or vice versa) is a plus.
- You have a good working knowledge of English (both spoken and written).
- You are analytical and good at solving problems.
- You are results-oriented and decisive.
- You are innovative and have experience in improving operational processes.
- You are customer-oriented, persuasive, communicative, and cooperative.
- You are a team player.
- Location: Brussels, Belgium
- Start-date: ASAP
- Duration: Initial 3 month – following by a 1 year contract (until December 2024), with a further possibility of extension.
- Hybrid position
Send your CV to Khanyi Mabena at firstname.lastname@example.org or contact her on +31 2020 44502.