Quality Management Specialist
hace 8 meses
Upjohn Export B.V. sucursal Costa Rica
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how the Quality Management Specialist role will make an impact:
Provide assistance to Quality Management, Product Safety and Risk Management (PSRM) activities. Support in implementation and management of Quality Management (e.g., Policies, Procedures etc.) for all global PSRM activities.
To assist the Regional team and global PSRM in executing the Pharmacovigilance (PV) activities regarding PV requirements, as per existing regulations.
To maintain compliance within Global Product Safety and Risk Management (PSRM) and to strengthen the QM activities for affiliates.
Key responsibilities for this role include:
- Support for PSMF including all Annexes.- Support regional team in coordination with a service provider (who manages Non-affiliated regions) regarding PV activities.- Coordination and assistance of training activities for global PSRM personnel ensuring training records are maintained and inspection ready at all times.- Training assignments for global PSRM functions and others, like service providers- Assist Lead Quality Management, PSRM and Regional team in the notification, preparation, conduct of CAPA following Regulatory Authority inspections and internal and external audits (on-site and remote).- Collaborate with PSRM personnel to manage internal global and local audit programme, assist in response to draft audit report, corrective and preventative actions (CAPA). Validate and communicate final audit metrics for submission to PSRM Management/ Viatris ELT and Regulatory Authorities (as applicable).- Support audits and inspections specifically during unique office hours of Americas territories.- Generation and review of global and local SOPs and Work Instructions as well as effectiveness checks for those quality documents as and when applicable and assigned.- Support in the implementation and creation of Policies and Procedures within PSRM and related functions.- Ensuring compliance with the regulatory requirements and company SOPs. To keep abreast of the new regulations affecting Pharmacovigilance activities. Being aware of PV regulations of the developed markets like US, all American territories and EU is also expected.- Assist in the collection, dissemination, and implementation of Regulatory Intelligence within PSRM and related functions.- Support the Lead Quality Management with the completion of PV audit questionnaires.- Support the Lead Quality Management with the review of PVAs on quality management aspects.- Liaise with Global and local functions in performance of the above-mentioned tasks.- Participate in any other PSRM projects where Quality Management Team is involved, or any other task as assigned.- Build and maintain good relationships across functional units and company affiliates.- Support site head in updating Business continuity plan and to conduct Business continuity testing.- Keeps the global PSRM quality management system, including training assignments current and in line with international regulations, including Indian regulations.- The job holder will be required to prioritize work, based on expected or agreed timelines.- Whenever necessary interact with the relevant departments like Regulatory, Business Development, Clinical etc., to meet timelines and achieve the required outcome.- Keeping the best interests of the PSRM department in mind, he/she may need to take decisions on the action plan to achieve the expected outcome.- Should there be any process related deviations from defined regulations or company’s best practices, advice should be sought from the Lead Quality Management, PSRM and Regional Head, PSRM.
The minimum qualifications for this role are:
- Minimum 5 years industry experience or quality or document management experience.- Knowledge of global PV regulatory requirements.- Good time management skills with an ability to prioritize and plan the work for a productive and effective outcome.- Good presentation and communication skills, including diplomacy and excellent negotiation skills.-
- Good knowledge of medical and pharmaceutical terminologies.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
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