Quality Assurance Manager
Bucharest, Romania
3 zile în urmă

Job Description

The QA GMP Manager / QP has direct collaboration and partnership with all associates for implementation of the Novartis Quality Manual and Quality Management System in the CPO, to achieve a high level of quality and compliance.

He / she also supports adherence to current and proper over-sight for GMP / GDP area on relevant departments, as well as other GxP activities related to release activities for our drugs products.

Main accountabilities :

  • Managing complaints, deviations, CAPAs, support recalls, destructions, and archiving according to the Novartis Quality Manual and local / global written procedures;
  • Perform Duty of care check for our drugs products as the QP registered in our GMP License
  • Supporting GxP Quality Manual implementation, included but not limited to tracking of QA Manual implementation, writing / reviewing of LWPs / LPs as assigned by CPO QA Head;
  • Handling the local and global SOPs relevant for the Romania Organization
  • Maintaining current knowledge of relevant regulatory and legislative requirements and trends;
  • Ensuring, together with Country QA Head, previous preparation and facilitate the conduct and coordinate the follow-up of GxP related Health Authority inspections and internal audits at CPO level, vendor level and investigator sites;
  • Supporting assessment, qualification and management of local third parties;
  • Supporting Country QA Head in all GxP related activities as needed during absence of QA Managers / QPs;
  • Being responsible for implementing specific QA projects and reporting the related actions to Country QA Head;
  • Conducting proactive in-process quality and compliance review through monitoring of adequate Key Quality Indicators (KQIs) and assuring that gaps are addressed appropriately in order to mitigate risk;
  • Providing training to associates within the company, regarding local / global quality assurance procedure.
  • Minimum requirements

  • Qualified person certificate by ANMDMR for drugs - it’s mandatory
  • Degree in Pharmacy or related fields (such as Medicine, Biochemistry, Chemical engineering);
  • Fluency in English, both written and spoken;
  • Minimum 1 year of experience in the pharmaceutical industry in quality assurance / regulatory affairs
  • Solid knowledge of legislation and the quality assurance management systems;
  • Solid knowledge of the GxP area;
  • Experience in managing complaints and deviations;
  • Experience in training delivery.
  • Experience in implementing projects
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