Description
We have a new opportunity for a Quality Specialist to join a busy team to oversee compliance activities for quality assurance an validation tasks.Accountabilities:
* Supports project activities for activities related to qualification and 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 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
Candidate profile:
Education:
* A university or academic degree in Engineering, Chemistry, Pharmacy, Biology or equivalent.
Language:
Relevant Experiences: * Professional in German and English (spoken and written).
* Professional experience in QA / QC, Engineering, Production; very good GMP knowledge, experience of minimum 5 years in the pharmaceutical industry or comparable experience in other industries.
Please contact Beata Klecz on
Michael Bailey International is acting as an Employment Business in relation to this vacancy.