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Validation Manager - Biologics (m/f) Job ID: 10559

Disziplin
Quality/Production
Stellenart
Vollzeit
Ihre Aufgaben
  • Establish, write and maintain the Validation Master Plan for process validation

  • Support MS&T Head in ensuring that responsible departments execute and maintain the VMP activities including, annual revalidation process procedures

  • Maintain overview of validation state across sites

  • Cooperate with Quality based on feedback (e.g. via regulatory inspections, changes in regulations) to establish and maintain common approach

  • Develop the strategy for continued process verification (CPV) and review of the risk assessments for CPV

  • Set procedures & templates for respective validation documentation and validation master plan, provide guidance to facility impact and component criticality assessments

  • Maintain all activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections

  • Author complex validation protocols

  • Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation

  • Support equipment process qualification for new technologies. Ensure consistency with process needs defined by Manufacturing and/or Engineering

  • Understand potential risk areas/shortfalls and make sure that the site validation program is always inspection ready

  • Leads the validation group and is responsible for his team members

  • Monitor the production processes and process quality, and make improvements as needed

  • Performing all duties with respect to current GMP requirements and other pharmaceutical regulations

  • Represent the company during regulatory inspections

Region
Europa
Gehalt
Auf Anfrage
Eintrittstermin
Auf Anfrage
Ansprechpartner
Larissa Weber
Fon +49 89 416 117 0 – 0
Mobil + 49 152 295 555 62
Ansprechpartner
Larissa Weber
Fon +49 89 416 117 0 – 0
Mobile + 49 152 295 555 62
Mail larissa.weber@theentourage.de
Betreff Bewerbung für Job ID 10559 auf theentourage.de