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.
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