Description
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 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.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.