QA Compliance Specialist (m/f)
Start: as soon as possible
Duration: 6 months with possibility of extension
Location: Schaffhausen area
For one of my biggest pharma clients I am currently looking for a QA Compliance Specialist with the following skills set.
- Supports project activities as member ofQA Compliance for activities related to qualification / validation of equipment, utilities and facilities and associated change controls activities
- Review and approve Cleaning Validation Protocols and Reports (Revalidation, Verification, Product Transfers) including associated Risk Assessments and Deviations
- Perform Quality risk assessments in case of critical deviations and initiate escalation process if applicable
- Review and approve Process 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
- 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 (e.g. Sharepoint)
- Prepares training modules for QA Compliance and C&G
- Adheres to HSE guidelines and requirements
Education: (minimum/ desirable):
- A university or academic degree in Engineering, Chemistry, Pharmacy, Biology or equivalent.
* 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 (sterile / biotechnology / C> a plus) or comparable experience in other industries.
If you are interested in this position please send me your CV to k.blomberg (at) realstaffing.com and give me a call on +41 (0) 44 588 2636.
Looking forward to your application.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.