Cleaning and Process Validation Expert
Cleaning and Process Validation Expert - Basel-Landschaft
Jocelyn Blackham is recruiting for a cleaning and process validation expert to join a innovative company in the pharmaceutics and diagnostic industry at their site based in Basel-land on a contract basis until the end of 2020 with option to be extended.
The main purpose of the role will be to:
- Plan and schedule the execution of cleaning and process validations for pharmaceutical API and in vitro diagnostics.
- Develop and coordinate the creation of the corresponding sampling plans, based on statistical and risk-based models.
- Extract the cleaning and process validation relevant factors and parameters.
- Coordinate the preparation of cleaning and process validation plans and reports for pharmaceutical API and in vitro diagnostics, in collaboration with production and quality control experts, based on existing process risk analyses and existing CMA, CPP and CQA.
Further responsibilities will include:
- Training the employees for the implementation and monitoring the validation activities, in cooperation with the production and supply chain departments.
- Coordinating and supporting interdisciplinary process risk analyses with your specialist knowledge.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Previous' experience in cleaning and process validation for pharmaceutical products.
- Fluent in English and German (oral and written).
- Familiarity with state of the art GMP compliant process and cleaning validations of pharmaceutical API according to EU GMP Guide and ISO 13485 for in vitro diagnostic products.
- Familiarity with the requirements for GMP-compliant validation of production and cleaning processes and know how to transfer these into suitable validation specifications and statistically relevant sampling models by use of statistic tools.
This is an excellent opportunity to join a small pioneering company within the pharma industry.
For more information or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 78 251 65 95 or email applicationsckqls@ckqls.ch. Please could you send any correspondence in English. Please quote reference 47467 in all correspondence.