Description
* Corsier-sur-vevey
* Temporär
Job Details
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 local 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 local procedures 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 in scope of Technology transfers
* 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 5 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.
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 local 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 local procedures 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 in scope of Technology transfers
* 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 5 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.
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