Validation /Compliance Expert - sterile manufacturing

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Daily tasks:

Supports project activities related to qualification / 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

Candidate profile:

A university or academic degree in Engineering, Chemistry, Pharmacy, Biology or equivalent. Prior experience in validation and qualification of equipmentPrior experience in quality assurance and compliance tasksExcellent knowledge of GMP regulations

Excellent knowledge of German and English languagesMichael Bailey International is acting as an Employment Business in relation to this vacancy.