We have a new opportunity for a Quality Specialist to join a busy team to oversee compliance activities for quality assurance an validation tasks.
• Supports project activities for activities related to qualification and validation of equipment, utilities and facilities and associated change controls activities
o Review and approve Process Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
o Review and approve Cleaning Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
o Review and approve Equipment, Facility and Utilities Qualification Protocols, Reports and associated documents including Risk Assessments and Deviations
o Perform Quality risk assessments in case of critical deviations and initiate escalation process if applicable
• Supports project activities related to Quality Management System
o Writes / Reviews / Approves SOPs/Forms/reports associated with above duties and provide support for creation, maintenance and retirement of GMP related documentation in the respective databases
o Prepares training modules for QA Compliance
• A university or academic degree in Engineering, Chemistry, Pharmacy, Biology or equivalent.
Relevant Experiences: • Professional in German and English (spoken and written).
• Professional experience in QA / QC, Engineering, Production; very good GMP knowledge, experience of minimum 5 years in the pharmaceutical industry or comparable experience in other industries.
Please contact Beata Klecz on 0041 442152052
Michael Bailey International is acting as an Employment Business in relation to this vacancy.