QA Release Specialist
Novartis AG
Kundl, Österreich
vor 6 Tg.

Job Description

Responsible for incoming material batches release in particular ensuring each batch has been tested and released in accordance with the appropriate regulatory practices and GMP requirement

Area of Responsibility :

  • Information interface to other quality departments and other areas within Sandoz for API supplier management
  • Compliance with the law and the Sandoz guidelines regarding safety, ecology and protection of workers
  • Participation and collaboration on GMP workshops
  • Contribute to the reporting of quality-relevant performance indicators (KQI, CCIN, etc.)
  • Coordination of contract laboratories used by QAI incl. monitoring and API supplier evaluation
  • Implementation and verification of compliance with SOPs, GMP rules and documentation guidelines
  • Providing data and overviews (APQR, work reports, monthly reports and annual reports) - Responsible to perform external audits (suppliers, contract laboratories) when required.
  • Supplier management of sterile and non-sterile materials - Processing of complaints and collaborate with Supplier Manager for monitoring of supplier performance
  • Contribute to the development, setting and monitoring systems to ensure the quality and releasing the products in accordance with FDA, EC GMP and Novartis
  • Collaborate to the management of Quality Technical Agreements with contract laboratories, suppliers, customers and contract manufacturing partners
  • internal release of packaging materials (including Consumables and medicinal products)
  • Ensure material being released was purchased from an approved suppliers
  • On request, conduct and monitor self-Inspection schemes for all sections. Monitor actions and corrections accordingly
  • Collaborate with Supplier Specials to ensure that suppliers is operating under a suitable quality system adequate for the type of material purchased (e.g. GMP, ISO, etc.)
  • Information interface to other quality departments and other areas within Sandoz for material supplier management
  • Collaborate on the management of Suppliers including qualification, approval, monitoring and auditing of suppliers
  • In collaboration with the other relevant departments, organize the investigation when incoming batches do not comply with specification and then organize the rejection and return of material, when relevant
  • Responsible to support inspections / audits performed by regulators, customers, clients, security, internal, GQA, etc.
  • Number of batches of incoming materials sentenced
  • Number of complaints and investigation managed
  • Assist in the reduction of operational costs through continuous improvement initiatives.
  • Qualifications : Education :

    Education :

    o University degree, preferably a doctor of chemistry, pharmacology, natural science or equivalent

    Languages :

    o Very good command of German (spoken & written)

    o Good command of English

    Experience :

    o Preferably 2-3 years post degree

    o 2-3 years experience in manufacturing product or in quality control / quality assurance

    Please apply online (Job ID 263976BR)

    Contact : Marcel Otto, Talent Acquisition & Staffing Business Partner

    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 the respective amount according to the Austrian collective agreement (at least € 44,286.62 per year on a full time basis), plus a potential market oriented excess payment.

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