Requirements: English
Company: WhatJobs
Region: Corsier-sur-Vevey , Vaud
Jobdescription
An exciting new 6-month opportunity has arisen to join us asQuality Assurance Process Validationfor 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 proceduresare 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 5years'' 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.
Kata Kulcsr