QA Process Validation Expert.

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.