QA Manager - Focus on IT Systems & Master Data Management
QA Manager - Focus on IT Systems & Master Data Management
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1 Vacancy
Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
Thats what makes us Roche.
The opportunity:
As part of the Quality Unit onsite the team QA Facility & Engineering ensures GMP compliance of all production facilities at the Basel Drug Substance Manufacturing site. The teams responsibilities include the quality oversight of the qualification status of all production equipment automation systems laboratory equipment the building infrastructure the utilities IT systems and OT systems of all production areas onsite.
In this position:
You have endtoend quality oversight on the maintenance of GMPrelevant master data (eg. ERP and LIMS systems)
You provide QA input to define local procedures regarding master data maintenance and assure cGMP compliance
You function as an author of corresponding SOPs and align all involved stakeholders in local roles as well as globally within the Roche manufacturing network
Within your technical field of expertise you review and approve GMP records that cover technical change management deviation management & CAPAs risk assessments and SOPs as well as records from IT business partners.
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 a university degree in life sciences or engineering along with at least 2 years of demonstrated experience in Quality Assurance at a pharmaceutical manufacturing site.
Desired skills:
Practical experience in deployment projects of major IT systems (eg. ERP LIMS)
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. You manage to drive quality awareness with operations partners at all levels by integrating regulatory requirements analytical problem solving and scientific rationale.
Excellent German and English language skills both written and spoken.
This position is fixed term for 2 years.
For a complete application we kindly ask you to include an uptodate CV and relevant certificates.
We are looking forward to your application!
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver lifechanging healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Manager
Employment Type
Full-Time
