Greater Munich Metropolitan Area
- Fulfill requirements as described in §1 Bundesapothekerordnung, comprising pharmaceutical activities as described under §2 Abs. 3 Bundesapothekerordnung. - Ensure that the handling of pharmaceutical goods in Germany are performed according to authority regulations and the needs of the respective national organization. - Responsible for ensuring that all aspects of Quality Assurance in the operational business are compliant with the Quality Assurance Agreement, cGMP, cGDP, regulatory requirements & the Sandoz Pharma Quality Manual. - Responsible for leading and distribution of responsibilities in the QA Germany team - Leading the respective platform of commercial organization to ensure oversight of operations impacting GxP in all sites & countries. - Driving improvements in compliance with regulatory and Sandoz expectations and move to the next level of quality maturity. - Building the capability of the QA organization in all sites and countries, but specially in the German quality organization, and develop associates to their full potential. G - Global leader of leaders responsible for the success of a Quality subfunction at the global level. - Working in accordance with legislation, internal rules, good practices and business objectives. - Management and development of associates
As Head of Commercial QA take over the responsibility to develop and maintenance the QMS and strategic framework and lead and drive initiatives to contribute business continuity and expansion objectives. Supervise local responsible persons for Quality Assurance including goal setting and performance review. Plan and monitor Commercial QA budget. Support internal and cross-departmental projects, for instance on operational excellence and business development.
As GDP Responsible person assume overall responsibility related to storage, distribution and wholesale activities of medicinal products and medical devices. As Head of Commercial QA take over the responsibility to develop and maintenance the QMS and strategic framework and lead and drive initiatives to contribute business continuity and expansion objectives Manage and improve s system for the handling of product quality complaints. Assessment and report of quality issues that could lead to a recall. Cooperation with internal and external stakeholders to optimize business process. Participate on GDP supplier audits, self-inspections and customer audits to ensure full compliance with current guidelines.
Computerized System Validation (CSV). QMS: Management and assessment of Deviations, Change Control, CAPAs and Risk Analysis. Follow up and management of quality and non-compliance issues, recalls and falsified medicines Managing of the Corporate Audit Team ensuring appropriate overview of global GRT suppliers landscape and drafting of the Corporate Annual Planning following a risk based approach. QKPI reporting and Integrity Board report. Internal and external audits and related tasks.
•Protocol and report drafting: oIQ/DQ: Equipments and rooms. oOQ/PQ: Equipments and rooms. oProcess. oMedia Fill. oCleaning. •Microbiological analytical method validation. •Technical report drafting. •Validation Master Plan Drafting. •Calibration Master Plan Drafting. •Support to external calibration qualification suppliers •Deviation of specifications. •CAPA system. •Technical changes. •Support to external audits.
•Protocol and report drafting: oIQ/DQ: Equipments and rooms. oOQ/PQ: Equipments and rooms. oProcess. oMedia Fill. oCleaning. •Validation Master Plan Drafting. •Calibration Master Plan Drafting. •Deviation of specifications. •CAPA system. •Technical changes. •External audits.
•Notification of the exported batches. •Drafting of the notification dossier. •Notification of new products. •Notification of changes in the frame formulation or packaging. •Official documentation processing: Free Sale Certificate.