Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are now hiring for our team:
Senior Computer System Validation Manager (f/m/d)
Your new challenges which will inspire you:
- Plan and manage assigned computer system validation projects ensuring the validation of corporate computerized systems used across GxP-operations are conducted in compliance with applicable regulatory requirements and internal procedures.
- Track validation deliverables and provide periodic progress reports to stakeholders
- Author, review and/or approve applicable documentation such as specifications, SOPs, validation plans and reports, test protocols and reports
- Executes/facilities gap analysis and/or risk assessments to ensure evaluation of current computer systems to ensure compliance with part 21 CFR Part 11, Annex 11, and GAMP 5.
- Conduct impact assessments for changes impacting validated computerized systems. Acts as change owner for assigned projects
- Act as subject matter expert during regulatory inspections
- Provide coaching, training and/or mentoring to System Administrators, IT Technicians and Contractors
Your profile that will convince us:
- Bachelor’s Degree in Computer Science, Electrical Engineering, Chemical Engineering or other Technical Science with minimum 5 years experience in the field of pharmaceutical industry related to qualification and validation practices
- Experience in planning, deploying, managing and sustaining computer system validations
- Ability to manage validation and qualification activities and good business process understanding
- Experience from ERP/SAP and MES systems is a strong advantage
- Excellent command of English
- Strong collaboration skills through international organizations and team player mindset
Our attractive benefits for you:
- Wide range of tasks in an international setting, flexibility and personal responsibility
- Reliable employer with generous employee benefits and a salary customary in the market.
- Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant, extraordinary staff events and many more:
The minimum gross wage according to the collective agreement (chemical industry) for your new job is EUR 3.557,47. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay wages higher than collectively agreed.
We are looking forward to new, committed employees who join forces with us to promote our strong growth in order to keep enabling our patients to live a better life – because it is in our blood! Is it in your blood too? We are looking forward to receiving your application via our online career portal.
Manfred Weinzerl, MSc
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien,
T: +43 (1) 610 31 – 4515