QA Manager Analytics & Stability

Novartis Technical Operations / Aseptics
  • Unterach am Attersee
  • Vollzeit
  • Berufserfahrung
  • 12.9.2017

Sandoz
Development Center

Unterach

Sandoz is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to discover new ways to improve and extend people's lives.

QA Manager Analytics & Stability

Area of Responsibility

  • Oversee the quality standards in all activities related with our development laboratories
  • Review and approve analytical method validation protocols as well as stability program documentation
  • Oversight regarding re-qualification and calibration tasks (Qualification Master Plan)
  • Review and approval of equipment qualification documentation
  • Support for the compilation, approval of respective risk analysis and assessments
  • Support for processing of quality records (OOS/OOT, Deviations, Change Controls und Quality Events) related to analytical development and stability and approval of the respective records
  • Preparation and execution of the SDC (Sandoz Development Center) self-inspection plan
  • Support during inspections and audits as QA Subject Matter Expert for Analytics and Stability Programs
  • Support for the compilation of SOPs (standard operating procedures), review and approval of SOPs
  • Release of analytical/reference standards

Qualification

  • Experience in the pharmaceutical industry, especially in the area of quality control and/or quality assurance with a focus on analytics, analytical method validation, equipment qualification and product stability
  • Academic degree in life sciences with a strong background in chromatographic methods
  • Knowledge of regulatory guidelines (ICH, ISO, FDA, EU, etc.)
  • Ability to meet deadlines and deal with change and high-pressure situations
  • Ability to work in teams (also cross-functional), good interpersonal skills
  • Strong communication skill in English (C1); fluency in German preferred but not mandatory
  • Solid organizational skills

Please apply online at: https://www.sandoz.com/careers (Job ID: 219290BR)

Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, training possibilities and global career opportunities). In accordance with the Austrian collective labor agreement, we have to advise you that the minimum annual gross salary for this role is EUR 42.914,--. We are willing to overpay.

Contact: Karin Stichlberger | HR Manager | +43 7665 8123 108

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Novartis Technical Operations / Aseptics

Mondseestr. 11
4866 Unterach am Attersee
Standort

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Der österreichische Produktionsstandort von Novartis Technical Operations, Aseptics, in Unterach am Attersee entwickelt, fertigt und vermarktet injizierbare Sterilarzneimittel zur Therapie von Krebs- und Immunerkrankungen. Am Standort befindet sich auch das Sandoz Development Center Unterach. Die…

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