* Supports project activities as member of QA Compliance for activities related to qualification / 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 as member of QA Compliance for 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 and C> Stein
* Adheres to HSE guidelines and requirements
Education: (minimum/ desirable):
* A university or academic degree in Engineering, Chemistry, Pharmacy, Biology or equivalent. * Professional experience in QA / QC, Engineering, Production; very good GMP knowledge, experience of minimum 5 years in the pharmaceutical industry (sterile / biotechnology / C> a plus) or comparable experience in other industries.
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