QA Process Validation Expert.

job details

summary.

speed up the application by sharing your profile

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 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.

 

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.

 

get in touch.

we are here to help you with your questions.

KK

Kata Kulcsár

  • Lausanne Professionals Life Sciences

related jobs.

see all jobs

Thank you for subscribing to your personalised job alerts.