Additional Cleaning Validation Act.  
Group Tormans
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48 dagen geleden

Objectives

After having processed the Standard Operating Procedures ( Safety & Quality) that are relevant for the scope of this assignment and qualification for writing, reviewing, approving and executing protocols and reports, hereby the scope of responsibilities :

1. Participating during functional meetings that are needed to perform the activities in scope of this assignment.

2. Routinely working hours during the day shift at the manufacturing site of MSD Heist o / d Berg; however some activities are also being performed at the production shop floor, thus working in an early / late shift is possible (exceptional during night / weekend shift).

3. Absences from the work station due to holiday, training or other reasons may not hinder the execution of this assignment.

4. Homework is allowed in exceptional circumstances but may not hinder the execution of this assignment.

5. Working at days when the site is closed is allowed.

Tasks

1. Writing, reviewing, approving and executing protocols for cleaning projects (development and validation) that are assigned to him / her.

2. Writing, reviewing, approving reports for cleaning projects (development and validation)

3. Coordinating the activities (planning, execution, finalization) together with internal (validation, production, planning, quality, laboratories, ) and external (global support functions, suppliers, ) parties.

4. Writing and updating procedures or work instructions within the scope of the activities.

5. Managing changes, including the performance of any impact assessments on the validated state of cleaning processes, in the MSD Global Change Management system that are relevant for this assignment.

6. Handling deviations in the MSD Global Deviation Management system, including the execution of problem solving, that are reported during validation activities or during routine production activities related to the cleaning processes in the four production units at MSD Heist.

7. Performing periodic reviews of the different cleaning processes to control the validated state.

8. Participating during internal and external audits for the projects he / she is working on.

Diploma :

  • Pharmacist or Industrial / Chemical Engineer (Process techniques, Chemistry, Biology,..)
  • Experience :

  • Some experience in Validation and / or Project is an advantage
  • Technical skills :

  • The ability to implement theoretical technical knowledge into practice and to use this knowledge in a technical environment
  • The ability to work on a project base
  • Advanced knowledge of English (talking / writing / reading)
  • Good technical writing skills
  • Characteristics :

  • Fluent / Communicative / Diplomatic
  • Team player / Collaborative
  • Motivated to work in a challenging environment
  • Quality and scientific mindset
  • Action-oriented
  • Analytical thinking
  • Balanced between pragmatic and detail-oriented
  • Flexible / Committed
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