Contribute and support the Benelux Country Quality Heads/RPs in the management, execution and maintenance of Country Quality Systems across the Commercial entities in Benelux, in close collaboration with the concerned functions responsible for GxP and health-regulated activities.
The Benelux Quality Officer will contribute and support the Country Quality Heads (CQHs) for a limited amount of activities (to be agreed upon, but e.g. including the Product Quality Review (PQR) as described below in Belgium as well as the Netherlands:
Management of Country Quality system:
• Define, implement and maintain a Country Quality system applying to GxP and health-regulated activities related to the development, manufacturing, distribution and commercialization of all products under development or marketed by Sanofi Business Units or through partnership agreements, in compliance with Sanofi Quality reference standards; Note: GCP is under the responsibility of the Clinical Study Unit. Cooperative efforts should be made by both parties to ensure consistency in quality management principles and operations.
• Assure compliance with and implementation of EU GDP and local regulations.
• Provide quality leadership across the country organization, with a priority focus on activities pertaining to quality of products, information and services.
• Enhance Quality culture & promote Quality mindset into the country governance, working principles and ways of operating;
• Coordinate a network of professionals designated in each country function involved in GxP and health-regulated activities and embark them to address all matters related to quality per the defined process
Country Quality documentation management system:
o Ensure that a process for management of GxP documents and records is in place in all GxP and health-regulated areas, considering data integrity principles;
o Maintain the Quality Documentation system to ensure the required quality documents are in place, in use and up to date at country level for the Quality function and support the other GxP and health regulated areas to comply with the same requirements in their respective domains;
o Implement a process of screening of released/updated Global Quality documents and local Country regulations, to capture the requirements that must be transcribed into Country Quality documents;
o Notify the GxP and health regulated functions of these updates, write and update when required the local Quality documents, ensure assignment and tracking of training & implementation at country level.
Country Quality audits and GxP Regulatory Inspections:
o Implement and maintain appropriate process and tool to ensure continuous audit and inspection readiness, in particular through the use of the Inspection Readiness Tool for Affiliates;
o Act as the support for the primary Country contact for GDP/GMP system Quality audits and support Global Quality Audit team in their preparation, conduct and follow-up.
o Support the management of Country Regulatory Inspections or other health-regulated processes owned by the CQH and provide support and coordination to other GxP functions in Country Regulatory Inspections for processes in their respective areas of responsibilities, ensuring contribution of concerned functions at Global level (as needed).
o Ensure that inspections of GxP or other health-regulated activities are reported by the relevant function in the appropriate Global database.
o Support the management of Audits and Inspection (preparation, CAPAs definition and follow up);
o Define and implement an annual GxP Self-Assessment/GDP Self-Inspection strategy for GxP and health-regulated functions within the country organization based on risk management criteria. Ensure coordination of the execution of this annual audit plan.
o Evaluate trends in Country Quality audit findings that may affect the Country Quality system and communicate to appropriate global functions the audit findings that require improvement.
Training: Training to quality-related matters: organize and manage information sharing, training sessions or programs related to processes owned by the CQH for concerned country associates, according to Sanofi standards and regulatory requirements;
Country Quality Review:
o Contribute to prepare and carry-out an annual Country Quality Review and monitor the related Quality Program and Action Plan follow-up;
o Organize the related meeting to present the outcomes to Country Senior Management Board, as per defined process.
Deviation and Corrective-Preventive Actions (CAPA) management: Maintain and continuously improve the deviations & CAPAs management system and manage those under direct responsibility of quality department;
Change Control management: Manage the changes that may impact GxP or health-regulated process or operations as per defined process set up at country level;
Country Quality key performance indicators (KPIs): Monitor and periodically report country quality KPIs defined by Global Quality, using the appropriate Global Quality computerized system;
Country Quality agreements (QA) handling: Ensure that valid and signed Quality agreements are in place for all GxP activities, establish new QA and update QA when required (with Sanofi manufacturing sites, distribution centers as well as with any third party sites);
Other service agreements handling:
o Ensure that valid and signed service agreements containing Quality dispositions and other mandatory quality related clauses are in place for all subcontractors of GxP and health-regulated activities;
o Ensure that relevant and up-to-date licenses are available for all suppliers and customers.
Quality management / quality oversight of locally managed GxP subcontractors:
o Manage Quality related activities of suppliers and GDP/GMP related subcontractors;
o Ensure an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities, either directly (being involved on selection process, qualification and performance of audits) or through coordination with the concerned country functions (as appropriate).
o Define and implement an annual external audit strategy for locally managed GxP and health-regulated 3rd party subcontractors based on risk management criteria. Ensure coordination of the execution of the annual audit plan.
Quality risk management: Ensure that quality risks are properly managed within the country (identification, assessment, control, communication);
Non-product related Quality events: Escalate and manage the events occurring at the country according to defined processes and standards (e.g. safety events, service complaints,…).
Administrative records: Ensure the availability of up-to-date administrative records (e.g. CV, Job Description, Training log, updated department organizational charts) for the Quality team and encourage other GxP functions to achieve the same;
Computerized systems: Ensure the maintenance of an up-to-date local inventory, together with relevant IT functions, and that local computerized systems in use within the country for GxP activities are in compliance with regulations and standards.
Quality of products:
• Oversee product distribution issues including temperature excursions;
• Provide support in the management of product recalls; Ensure prompt execution of recall operations in coordination with other functions in the country (e.g. regulatory, supply chain, medical) as per global recall process and local recall process.
• Escalate to CQHs, as necessary, Quality events occurring at a country level according to defined processes and standards - manage subsequent quality and or product quality alerts (as appropriate);
• Support management of product protection (counterfeits) and parallel trade issues in line with global processes;
• Providing support in maintenance of any required site licenses for Country activities;
• Contribute to the management of out of stock situations in coordination with country and global functions to ensure quality contribution in communication to relevant authorities;
• Ensure that products are being distributed only to validated customers as per local procedures;
• A University degree in Pharmacy or science e.g. biomedical science; pharmaceutical science, chemistry. minimum 2-3 years - experience of RP required
• Solid experience in GxP particularly GDP and GMP areas & other health regulation applicable in Pharmaceutical industry
• Strong knowledge and experience in quality management system
• Well-organized, strong written and oral communication skills and ability to manage multiple priorities & urgencies
• Ability to work transversally in a matrix organization & to foster a process simplification approach while meeting compliance requirements
• Ability to easy & quickly adapt to changing situations and priorities.
• Committed to customers, result oriented and decision making
• Ability to prioritize workload based on patient safety and commercial risk assessments
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