REQ-10003985
апр 29, 2024
Poland

Сводка

We are seeking a Deputy of GDP Responsible Person & Compliant Manager to help us to implement and supervise the proper functioning of the quality assurance system (QMS) for products distributed by Novartis Poland.

About the Role

Location: Warsaw/Błonia, Poland #LI-Hybrid

Key Responsibilities:

  • Monitoring and interpretation of up-to-date requirements of GxP as well as requirements of the pharmaceutical law with regards to distributed products.
  • Implementation and improvement of the quality management system (QMS)
  • Conduct GDP monitoring in pharmaceutical warehouse, conduct QA investigation for noncompliance, follow up the corrective actions.
  • Monitor actions and corrections accordingly.
  • Monitoring and overseeing quality incidents. Performing investigation and identification of a root cause of deviations.
  • Replacing upon request GDP Responsible Person in matters related to the quality assurance system in the field of distributed products.
  • Analyzing trends of detected deviations.
  • Ensure all required actions are taken appropriately and in a timely fashion.
  • Participating in the work of the Risk Assessment Team and the Validation Team
  • Ensure that all drug products are released for distribution in accordance with the GDP requirements.
  • Implementing and maintaining change control.
  • Carry out due diligence checks and ensure that suppliers and customers are qualified.
  • Ensuring relevant customer complaints are dealt with effectively and approve any returns to saleable stock.
  • Making decisions on the disposal of medicinal products: returned, not meeting the quality requirements, withdrawn, or falsified,
  • Planning, initiating and monitoring basic GxP-training for aemployees in regular intervals.
  • Reporting adverse events / special case scenarios related to Novartis products.
  • Managing of the complaint process, registration of complaints, contact with customers, evaluation of investigation reports.

Essential Requirements:

  • Pharmacist with an active License to Practice
  • Min. 2-year work experience in a pharmaceutical warehouse
  • The person does not simultaneously perform any of the following functions: Responsible Person in another pharmaceutical warehouse (including a pharmaceutical warehouse of veterinary medicinal products and a pharmaceutical warehouse trading only in medical gases)/ Manager of a pharmacy, hospital pharmacy department or pharmacy point/ Manager of a medical facility for animals.

Desirable Requirements:

  • Previous activities connected with Good Manufacturing Practises
  • Great English both written and spoken
  • Basic knowledge of the SAP system is desirable.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn morehere: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive:

Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), employment at Top SI Employer, Unlimited learning and development opportunities, 1y contract.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Operations
Pharmaceuticals
Poland
Warsaw
Quality
Full time
Temporary (Fixed Term)
No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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REQ-10003985

Deputy of GDP Responsible Person & Compliant Manager

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