Beschreibung
Global pharmaceutical company is looking for experienced QA manager to take charge for projects related to quality compliance of sterile products.Accountabilities:
* 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 (e.g. Sharepoint)
o Prepares training modules for QA Compliance
* Adheres to HSE guidelines and requirements
Requirements:
* 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 plus)
Please contact Beata Klecz on
Michael Bailey International is acting as an Employment Business in relation to this vacancy.