Baxter Validation support in Belgium, Belgium

The job

The job is a great opportunity to develop your professional career in the team ‘Manufacturing Product Development’ of our manufacturing Plant. You will give support in qualification and project activities for processes validation and equipment qualification for the PL department in accordance with internal and legal requirements.

Main responsibilities :

Act as a validation support for projects and periodic evaluation on qualification activities :

• Prepare validation documentation in compliance with Baxter and cGMP requirements and assure application of these requirements • Prepare and implement FAT, IQ, OQ & PQ Protocols. • Organize traceability throughout the whole project validation file (from URS to PQ). • Organize and coordinate FAT, IQ, OQ, PQ activities with the different involved departments and in such a way that all of them concur to the timeframes committed with the project leader. • Analyze, interpret, document and report the testing results. • Collect and approve results of validation activities, assure issuance of reports and allow release of impacted product in accordance to internal procedures • Ensure the follow-up and tracking of the validation’s activities. Update the validation documentation system. • Maintain the validated state through the periodic evaluation process

Develop and deliver training to employees to cover the validation activities.

Participate in the communication of the good validation practices

Who you are

  • Graduate /Master in Engineering or Science or equivalent through experience

  • Knowledge of Pharmaceutical Industry requirements

  • Good knowledge of cGMP

  • Experience in validation

  • Good understanding of industrial processes and industrial control systems

  • Good knowledge of current European and FDA regulations

  • Teamwork orientated

  • Good communication skills

  • Good problem solving and critical thinking skills

  • Very good knowledge of English (written & spoken)

Job: *Engineering

Organization: *Baxter

Title: Validation support

Location: Belgium-Belgium-Lessines

Requisition ID: 170005LM