Qualified Person (m/f)

  • Schaftenau
  • Vollzeit
  • Berufserfahrung
  • 3.12.2019
  • Stelleninserat
  • Arbeitgeber Einblicke
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Qualified Person (m/f)

Verantwortungsgebiet
Qualified Person (m/f), Schaftenau, Austria

4! new Biosimilars were launched in the past two years, doubling the amount of Biosimilars marketed by Sandoz worldwide. New Biopharmaceuticals marketed by Novartis Pharma will be released to the market by the QP team of Sandoz in Schaftenau. Therefore, an increase of our capacities is necessary.

Your Responsibilities:

Your responsibilities include, but are not limited to:

  • Responsible for the decision on the use of batches of finished products
  • Responsible for the review and approval of shipment under quarantine of finished products, master batch manufacturing records, control procedures, analytical methods, stability protocols, APQR, training plan and report of responsible people for technical release of API, intermediates and bulk product, quality plan, manual CoA/CoC - participation in investigation on critical complaints, OOS/OOT, recalls and escalations
  • Responsible for the review of quality agreements, change controls, process validation protocols/reports, analytical transfer activities, complaints, annual reports, certificates (Gluten, PVC etc.), shipment under quarantine of bulk products, packaging under quarantine
  • Participation in the execution of risk assessments, audits and inspections
  • Implementation of GMP training courses

Qualifikationen
What you'll bring to the role:

  • Degree in the natural sciences (pharmacy, chemistry, medicine, biology, microbiology)
  • Qualified Person (QP, 2001/83/EU, AMBO 2009)
  • Proficient in English and German (read/write/speak)
  • Several years of experience (> 3 years) in the release of medicinal products for human use

Desirable requirements:

  • Excellent organizational skills, great teammate, flexible and dedicated personality
  • Ability to coordinate a number of tasks simultaneously, prioritize and deliver against tight timelines
  • Excellent decision-making mind-set including good communication (written and spoken), attitude to resolve challenges, interdisciplinary thinking
  • Ability of accurately balancing between efforts, risks and benefits

contact: Jennifer Kriedemann, Talent Acquisition & Staffing Business Partner, +44 7525 702920

Why consider Novartis?
750 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.

We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least EUR 61,167.54 per year on a full time basis).

We are Novartis. Join us and help us reimagine medicine.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.