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Commercial Quality Officer PL/EE & GDP Responsible Person PL

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Want to raise standards on a global scale? As a Commercial Quality Officer PL/EE & GDP Responsible Person PL, you’ll have the freedom to shape the way we develop and deliver our products worldwide.

 

Commercial Quality Officer PL/EE & GDP Responsible Person PL

Warszawa, Mazovia Province 

Competitive Salary & excellent benefits package

 

The primary responsibility of the Commercial Quality Officer & Responsible Person Deputy (Health) is to provide leadership for excellence in Quality and Compliance of all Health products and processes within the supply/distribution chain, including embellishment. The CQO will: support Regional Quality Manager to facilitate quality continuous improvement activities; assure proper quality systems are developed to comply with current regulations such as relevant GMP and GDP; implement processes and procedures and observe/audit for compliance; establish objectives for Quality improvement within the Poland & Baltics region; provide feedback to the regional manager on performance against relevant internal and external quality, regulatory/statutory requirements; serve as a resource for information relative to all aspects of products and process quality; facilitate the ‘right first time’ approach and implementation of new products and processes; and support and integrate continuous improvement principles within the region through proactive communication, partnering, training and education.


This position is responsible for ensuring that the region maintains compliance with applicable regulations as appropriate while also supporting and enabling the business to achieve its business objectives.  The Commercial Quality Officer (Health) must work effectively with internal parties, manufacturing sites, third parties, external bodies and corporate personnel. As Responsible Person Deputy Perform all tasks related to the distribution of RB’s medicinal products in accordance to current legal requirements and regulations, Act on medicines, Act on narcotic and psychotropic substances, Good Distribution Practice, European Directives, local HA instructions and internal SOPs.  

 

Key challenges:

 

  • Ensuring that commercial management teams understand and fulfil their obligations to run a compliant business
  • Taking a firm position on product quality and compliance matters despite commercial pressures and escalating to senior management where required
  • Ensuring that the QMS remains fit for purpose by accommodating changes to local regulations and RB policies
  • Ensuring that changes to products are assessed and managed correctly through an established change management system

 

Knowledge/experience required: 

 

  • Education in pharmacy with at least 2 years of experience in wholesale and/or pharmacy
  • Good understanding of regulatory, GMP and GDP requirements relevant to a regulated product e.g. EU GMP, EU GDP, WHO, PIC/S, CFR 21 Part 210/211 any additional local regulation for medicines and narcotics
  • Good understanding of international standards e.g. ISO 9001, ISO 13 485  ISO 22 000, HACAAP
  • Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP
  • Language skills appropriate to the assigned country and/or regional cluster (Polish)
  • Very good spoken and written English
  • The active category B driving license
Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.

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