Wichtigste Eigenschaften
- Arbeitsort
- Krems an der Donau, Niederösterreich
- Unternehmen
- Powerserv Austria GmbH
- Tätigkeitsbereich
- IT
Allgemeine Beschreibung
Einsatzort 3500 Krems an der Donau Arbeitszeit 38 Std/Woche Entgelt ab 3426,58 €/Monat Our client is an international company in pharma industry, located in Krems an der Donau. Key activities & responsibilities Leading assigned Commissioning, Qualification and Validation (CQV) activities focusing on Computer System Validation (CSV) Sub-system owner (SSO) for CSV Additionally support CQV activities for equipment, processes, and sterilizations Development and approval of CQV Plans and Reports Provide technical and CQV knowledge to equipment and systems owners including best practices and optimizations Establish and/or participate in risk analysis and assessment to support CQV activities and change management Support Change Management, Deviation Management, and CAPA Management process on site and timely closure of tasks from the aforementioned Follow GMP, company, and local regulations regarding safety and CQV activities Work closely with IT, Automation, Quality, CQV, and Productions to ensure systems are compliant Support site CQV program by conducting periodic reviews, requalifications, Sanitization/Sterilization in Place (SIP) and Performance Qualifications (PQs), Commercial off-the-shelf (COTs), in addition to undertaking Subject Matter Expert responsibilities. Work in an interdependent team and with stakeholders to ensure facility and equipment maintains qualified and validated status Initiate and support continuous improvement activities within CQV and the site Qualification Degree in (Bio)Chemistry, Process Technology, Biotechnology, Pharmaceutical Technology, IT, Engineering or comparable work experience 2 years experience in Computer System Validation Strong organizational, analytical, and problem-solving skills Strong troubleshooting skills with the ability to explain technical to non-technical stakeholders Fluency in written and spoken German and English Very good knowledge of MS-Office applications We offer Full-time position 38h Working hours Mon - Fri 8.00 - 16.00 Position limited: 2 years The chance to work for an international group Der für diese Position vorgesehene kollektivvertragliche Brutto-Mindestverdienst beträgt EUR 3426,58 pro Monat. Bei entsprechender Qualifikation oder Berufserfahrung ist eine Überzahlung möglich. Ihr Job-Kontakt: POWERSERV Austria GmbH Katrin Prilisauer Favoritenstraße 80 1100 Wien +43 664 80303 1112 [Apply online]
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