Viatris AS is seeking Quality Officer (2 years Fixed-Term Contract)

Key Responsibilities For This Role Include

Every day, we rise to the challenge to make a difference and here’s how this role will make an impact

·        To ensure compliance with current EU-GDP and EU-GMP guidelines and applicable national regulations

·        To manage and develop quality and regulatory compliance systems in line with EU requirements and Viatris global policies.

·        Responsible for the appropriate management of product quality complaints in line with legal requirements as well as with Viatris Global Policies.

·        Ensure that marketing materials are compliant with Viatris internal and compliance regulations and the national regulations.

·        Review, investigation reports, compile Quality Investigation Reports (QIRs) and Quality Defect Reports (QDRs) to ensure that product investigations and complaints are closed out in a satisfactory and timely manner.

·        SOPs update / creation for local operations in line with Viatris Global Policies , EU-GDP and national regulations

·        Manage the self-inspection and the risk management program and participate in internal and external inspections.

·        Effectively manage corrective and preventative action plans and that they are effectively implemented, monitored and closed out.

·        Maintain change control process to manage all planned major changes with GDP or GMP impact.

·        Liaise with NOMA Regulatory Agency on all aspects of pharmaceutical product quality.

·        Other activities related to Quality, Compliance, marketing and/or GDP/GMP might be added when applicable.

The Minimum Qualifications For This Role Are

·        Strong interpersonal skills – robust with natural authority, easy going

·        Works well in teams and alone

·        Service minded; a ‘doer’ – getting things done, also when the pressure is high

·        Ability to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity

·        Have a strong understanding of the Quality processes and have a quality mindset

·        Must be customer (internal/external) focused and able to deal with ambiguity

·        Able to develop a culture of continuous improvement across the department

·        Ability to establish a good collaboration with internal and external stakeholders

·        Language skills: Norwegian and English at negotiation level

A t Viatris, we offer competitive salar ies , 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.