For our customer located in Vienna/Austria we are currently looking for a: QA Officer MES Projects (m/f/d)
- Start in September 2023 for nine months with possible extension up to 2025.
- Working with you in our team with QA experts, supporting day-to-day MES/QA project activities, adding thought leadership on Review-by-Exception, Data-Integrity, MBR Lifecycle Management. Together we’ll be promoting and leveraging MES abilities throughout the Manufacturing and QA organization to accomplish maximum business benefits.
- Minimum 50% on-site in Vienna, 75% is preferred.
Tasks & Responsibilities
- Quality Representative for multiple MES deliveries (participation in local & global meetings).
- Collaboration and control for a uniform MBR design approach across all production sites.
- On-site for design workshops, test management, quality overview at MBR verifications.
- Compliance with data integrity e.g. for data transfers (Scada, PCS, OSI PI).
- Creation, revision of standard operating procedures for MES.
- Audit Support for MES System.
- Creating and/or reviewing risk assessments and MES MBR verifications.
- Providing compliance advice and guidance to MES and Automation project managers, project
team, and IT Validation Leads. - Challenge status quo and existing requirements for MES projects.
- Reviewing and approving change controls.
- Assisting in Regulatory Inspections and Corporate Quality Audits.
- Supporting activities on dataflow from equipment to MES to ensure data integrity.
Must Haves
- Minimum Batchelor degree, and extra education in relevant area.
- Experience in MES MBR projects, preferably with PAS-X
- Experience in CSA / MBR Verification
- Knowledge in requirements for the creation and execution of MBRs and batch review according to AMBO and additional regulations
- Fluency in German and English
Nice to Haves
- Experience with Global MES Delivery and/or MES Center of Excellence
- Background in plasma, fractionation, formulation/fill/finish, packaging.
- Kneat Validation documentation
- Deep knowledge of FDA 21 CFR Part 11, EU GMP Vol 4 Annex 11, GAMP5 second edition.
- Thought leadership on Review-By-Exception, promoting and leveraging
MES abilities in QA organization to maximize business benefits.
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.