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Validation Expert

Adsano Engineering AG

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Adsano ist als Dienstleistungsunternehmen international für namhafte Pharmaunternehmen tätig. Wir bieten als Technologiedienstleister Erfahrungen in den Bereichen Qualifizierung, Validierung, Kalibrierung und Qualitätsmanagement an. Die Erbringung von professionellen Personaldienstleistungen für den Verleih oder die Vermittlung von Fach- und Führungskräften komplettiert unsere Dienstleistungspalette.

Für eine Festanstellung bei einem pharmazeutischen Unternehmen in der Region Basel suchen wir per sofort oder nach Vereinbarung eine berufserfahrene Persönlichkeit als

Validierungsexperte

Job Profile

  • Establish, write, and maintain key elements of the Validation Master Plan for process and cleaning validation

  • Support Process Validation Lead in executing and maintaining the VMP activities (process and cleaning validation)

  • Partner with Quality based on feedback (e.g. via division, regulatory inspections, changes in regulations) to establish and maintain common approach and translate that for the site

  • Adhere to established procedures & templates for validation documentation and validation master plan

  • Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes

  • Review and interpret risk assessments for validation. Translate the critical process parameters and the process control strategy into a focused validation plan for process validation

  • Review and author validation protocols and reports. Support the execution at the shop floor

  • Collect and provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation

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

  • Validation Master Plan (VMP) elements that are assigned are completed and up to date

  • Meet established validation and revalidation milestones according to approved validation plans

  • No critical/major observations during audits/inspections, products maintained in constant state of validation

  • Launches implemented on schedule and on target without validation related issues. Deliver validation data that meet the target schedule and quality to support the required registration documentation

  • Validation approach meets Novartis QM requirements, health authority and industry standards

  • Training curriculum up-to-date

 Candidate Profile

  • Education (minimum/desirable): BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology

  • Languages: English fluent in speaking and writing. French is an asset

  • Experience/Professional requirement (for recruitment purpose)

  • 5 years experience in manufacturing/ manufacturing science and technology/technical development/Quality

  • Thorough understanding of manufacturing processes and related process equipment

  • Strong working knowledge of quality systems and regulatory requirements across multiple health authorities

  • 3 - 5 years experience in executing process validation

  • Expert in reviewing and writing technical reports

  • Proven experience in a cross-functional environment (e.g. multi-site, technical development, other functions)

  • Fundamental understanding of standard pharmaceutical analytical testing.

Es erwartet Sie eine interessante und abwechslungsreiche Tätigkeit in einem internationalen Pharmaumfeld. Sind Sie interessiert? Dann freuen wir uns auf Sie. Sehr gern nehmen wir Ihre Bewerbung per Mail (career@adsano.com) entgegen. Dabei sichern wir Ihnen selbstverständlich absolute Diskretion zu.