We have a new opportunity or an experienced quality assurance expert to support a busy team with QA compliance activities related to qualification and validation of equipment.
. 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
. 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.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.