Qualification and validation of equipment, utilities and facilities and associated change controls activities
Review and approve Process Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
Review and approve Cleaning Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
Review and approve Equipment, Facility and Utilities Qualification Protocols, Reports and associated documents including Risk Assessments and Deviations
Perform Quality risk assessments in case of critical deviations and initiate escalation process if applicable
Supports project activities as member of QA Compliance for activities related to Quality Management System
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 (e.g. Sharepoint)
Prepares training modules for QA Compliance Adheres to HSE guidelines and requirements
A university or academic degree in Engineering, Chemistry, Pharmacy, Biology or equivalent.
Prior experience in quality assurance and validation in the pharmaceutical environment
fluency in German and English languages required
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