An exciting new 6-month opportunity has arisen to join us as Quality Assurance Process Validation for our Biotech drug substance plant in Corsier-sur-Vevey.
Your role:
* Coach and assure quality systems are applied in a consistent manner
* Approve Quality Plans and Validation Master Plan and periodic reviews
* Assure correct implementation of CCPs and adequate handling of deviations and CAPAs in order to ensure the validated status
* Assure that GMP documentation is up to date and well applied
* Review, approve and maintain risk analysis
* Define, develop and support implementation and control compliance with corporate an MSSA Vevey standards
* Assure QA presence on regular project meetings
* Develop the execution strategy including rules & procedures for commissioning, qualification or validation of projects
* Develop the execution strategy including rules & procedures validation/qualification, review and approve protocols and reports
* Ensure that general procedures MSSA-Vevey are in line with GMP/Merck Serono guidelines
* Ensure and maintain an adequate level of qualification and validation for all systems and products through the validation master plan
* Review and approved protocols and reports from BPS/MFG related to process development and validation
* Follow deviations and change control linked to validation/qualification projects
Who you are:
- University postgrade degree in Science or Engineering
- Knowledge of cGMP regulations
- At least 2 years’ experience in a quality environment in pharmaceutical industry or equivalent, ideally in biotechnology
- Good interpersonal skills, with a positive attitude and the ability to support his colleagues in a context of growth and changes
- Good writing skills.
- French & English written & spoken.