Pharmaceutical Process Validation Support

Are you looking for a challenging role in which you play a key role in the production of high quality sterile pharmaceuticals?

• Graduated in a scientific field?
• Do you have at least a first similar experience?

  In this role, you will be responsible for managing and supporting various mixing and filling projects within our sterile manufacturing department. You will be involved in projects ranging from ingredient source changes to implementing new regulations such as ANNEX 1, including PUPSIT. Additionally, you will have the opportunity to carry out small to medium sized optimization and implementation projects, where your expertise and creativity will be invaluable.

  If you are driven, a team player and keen to contribute to the production of high quality medicines, we invite you to apply for this vacancy. We look forward to your application and welcome you to our dynamic team

  For more information, please contact our recruiter Kevin Van Roy at kevin.vanroy@professionals.randstad.be - Life Sciences Vlaanderen.
  

  key responsibilities

  Scope of work for this assignment:

  
  

  1. Manage and provide support to several compounding and filling projects (development and/or validation) within the sterile production department:

  a. API source changes

  b. Projects related to new ANNEX 1 requirements (e.g. PUPSIT)

  c. Realize small to medium optimization and implementation projects that are individually assigned

  2. Coordinate end-to-end project activities (i.e. planning, preparation, execution, implementation, service support) together with local teams of validation, production, planning, quality, and laboratories and with network of company experts:

  a. Write and execute protocols for the planned studies

  b. Witness development and validation studies

  c. Follow-up the sampling & testing plan with production and laboratories

  d. Evaluate study data results and write reports for the executed studies

  3. Execute process changes to APIs, excipients, primary packaging, and product contact materials and manage component specifications and qualifications of primary packaging components and product contact materials.

  4. Assist the quality and production department in handling deviations, and executing the investigations and activities for problem solving and corrective and preventive actions.

  5. Assist the Pharmaceutical Technical Operations (PTO) department in compliance driven activities such as the continued process verification program and annual product review

  6. Report into the PTO lead
  

  qualifications

  • You have a scientific degree (pharmaceutical sciences, engineer in life sciences/chemistry/industry/...).
  • You have relevant experience in pharmaceutical formulation and filling processes, and knowledge of sterile drug production technologies.
  • You work mostly in day shift at the site in Heist-op-den-Berg, but are also available when certain activities take place in shift work (so working an early/late shift is possible (exceptionally during night/weekend shift).
  • Working from home is allowed up to a maximum of 2 days per week, but should not interfere with the execution of this assignment.

    Technical Skills:

    • Ability to work on a project basis and within a team of technical experts
    • Advanced knowledge of English (speaking/writing/reading)
    • Skills in technical writing
    • Problem solving skills
      

      key benefits

      You will receive a contract with Randstad Professionals and a great job for an indefinite period of time.Furthermore, you can count on the following salary package:In addition, we also offer numerous training courses, fun activities, career opportunities, ... to guide you through your career.

      • Gross salary depending on your experience
      • Extra net allowance of â¬80 per month, on top of your net salary
      • Meal vouchers worth â¬7 per working day
      • Eco vouchers worth â¬250 per year
      • 12 extra vacation days
      • Possibility of hybrid working (working from home)
      • Vacation pay and 13th month
      • Hospitalization insurance
      • Pension savings
      • Company car with fuel card (subject to conditions) or mileage reimbursement