QA Manager Facility & Engineering (temporary 3 years)
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
As part of the Quality Unit on-site, the team QA Facility & Engineering ensures GMP compliance of all production facilities at the Basel Drug Substance Manufacturing site. The team's responsibilities include the quality oversight of the qualification status of all production equipment, automation systems, laboratory equipment, the building infrastructure, and the utilities of all four production areas on-site.
Key responsibilities:
* You have end-to-end quality oversight on the qualified state of all assets in your assigned area.
* You provide fit for purpose quality support for all the activities related to qualification & CSV, calibration, maintenance & reliability engineering.
* You review and approve GMP records that cover technical change management, deviation management & CAPAs, risk assessments and SOPs.
* You coordinate and facilitate complex investigations, root cause analyses, technical risk assessments, and continuous improvement projects.
* With your operations partner, you present topics during health authority inspections and internal audits.
Who you are:
To successfully fill this role, you bring the following qualifications:
* University degree in science or engineering with demonstrated experience in Quality Assurance at a pharmaceutical manufacturing site.
* Practical experience in commissioning & qualification projects in highly automated GMP production facilities.
* Well established confidence in setting precise guidance for QA compliance in technical changes, deviations and CAPAs.
* Your collaboration with partners is characterized by outstanding communication and team work.
* Excellent German and English language skills, both written and spoken.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Our success is built on innovation, curiosity and diversity.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Our employees benefit from extensive development and training opportunities, flexible working options, and various employee services.
Roche is an Equal Opportunity Employer.
#J-18808-Ljbffr