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Archiviertes Projekt - Validation Expert, Basel

Firmenname für PREMIUM-Mitglieder sichtbar

Februar 2021

Dezember 2021

CH-Basel

auf Anfrage

18.01.2021

CR/104639_1610726664

Projektbeschreibung

Our Client, a Global Pharmaceutical who is currently on an exciting growth curve are seeking a Validation Expert to be based at their Basel site for an initial 11-month contract with a strong likelihood for extension. The workload will be 50%.

Key responsibilities will include:

* Provides technical expertise (and may facilitate) pre-validation risk assessments using risk management tools.
* Works collaboratively and cross functionally to help ensure that process risks are analysed, appropriately controlled and appropriately documented.
* Ensures that all validation activities are compliant current Novartis requirements and cGMP.
* Manages deviations associated with process validation and makes recommendations for deviation resolution as well as prevention of reoccurrence.
* Provides technical expertise and recommendations for validation of major or complex changes in manufacturing.
* Authors and reviews process validation protocols (e.g. launches, weak point remediation) and related reports.
* Reviews MBRs and associated change controls. Supports the execution at the shop floor.
* Responsible to translate applicable process parameters and the process control strategy into a focused validation plan for process validation.
* Participates in pre-validation activities to ensure the success of commercial process validation.
* Provides technical expertise.
* Owns the Training Curriculum for its Job Description



The successful incumbent will possess:

* in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology.
* Fluent in English and German.
* 2-3 years experience in manufacturing/ manufacturing science and technology/technical development/quality.
* Thorough understanding of Biotech (mammalian cell based) manufacturing processes and related process equipment.
* Expert in reviewing and writing technical reports.
* Experience in biotech process validation or biotech cleaning validation (plan and Report writing)
* Fundamental understanding of standard pharmaceutical analytical testing.

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