Qualified Person

at  Viatris

Mylan Hungary Kft.
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 Qualified Person role will make an impact:

Major tasks and duties:

• Ensures the effective legislation requirements of manufacturing pharmaceutical products are fulfilled during the manufacturing, packaging, testing and handling of the medicinal products.
• Certifies the finished product batch before release for sale in the EU/EEA. Ensures the medicinal product meets the requirements of the Marketing Authorization.
• Certifies the partial manufacturing activity if the final certification site is not Mylan Hungary.
• Approves suppliers that are relevant from GMP point of view; Participates in supplier audits.
• Ensures that any deviations/non conformances are investigated and reported. Participates the evaluation and approval of these reports.
• Ensures that the manufacturing and packaging are done on qualified equipment with validated procedures. Ensures the testing of products is done by validated procedures.
• Reviewing deviations or changes in packaging, in quality control and in all the other departments of the QA system of Mylan Hungary to ensure that the records and changes have been authorized by the persons responsible in accordance with the quality system.
• Takes part in Health Authority inspections, internal and self-audits. Reviews and approves the reports or notes of audits and inspections.

Expectations towards jobholder:

• Profound knowledge of GMP guidelines and hosting GMP inspections. Must possess knowledge of all applicable regulated agencies that govern the industry. Must possess expert-level knowledge of Quality practices, processes and procedures.
• Accuracy, attention to details. The jobholder must demonstrate integrity- strict adherence to rules and pharmaceutical regulations. Decision making and problem solving. Ability to transfer his knowledge to others.
• Jobholder must possess M.Sc. in Life Sciences (Pharmacist, Chemical or Biological Engineer)
• Must have at least 1 years of working experience at pharmaceutical company. Experience at a packaging site is preferred.
• At least C1 level of local language (Hungarian) and English.

What we offer:

• Annual salary increase depending on performance
• Within the framework of the career ladder program, we provide an opportunity for advancement, which means an additional salary increase
• Employee-friendly planned summer and Christmas leave
• Guaranteed HUF 100,000 gross immediate payment after successful completion of the trial period
• Annual bonus, which can reach the amount of 1.5 months’ salary
• Travel subsidy: 100% reimbursement in case of public transport, 60 HUF/km in case of car use
• Free company bus services on constantly expanding routes (from several points in Hungary and Slovakia)
• If you move from a place of residence more than 100 km away to a place within 35 km, sub-rent support is provided, the amount of which is a maximum of HUF 100,000 net per month for 1 year
• Gross monthly HUF 7,520 sports support
• Workers’ life and accident insurance (the validity of which also extends beyond working hours): in case of critical illnesses, birth of a child, broken bones, surgical intervention for any reason
• Private specialist and diagnostic care at a private healthcare provider nationwide
• Employee referral program, with a minimum gross of HUF 300,000 if a candidate is successfully recommended
• Free work clothes insurance and cleaning
• Free English language training within the framework of the career program
• World-class machines, clean pharmaceutical industry environment
• A continuously developing company offering a secure future, which has tripled both the number of employees and its pharmaceutical packaging capacity over the past 10 years.

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.

• Ensures the effective legislation requirements of manufacturing pharmaceutical products are fulfilled during the manufacturing, packaging, testing and handling of the medicinal products.
• Certifies the finished product batch before release for sale in the EU/EEA. Ensures the medicinal product meets the requirements of the Marketing Authorization.
• Certifies the partial manufacturing activity if the final certification site is not Mylan Hungary.
• Approves suppliers that are relevant from GMP point of view; Participates in supplier audits.
• Ensures that any deviations/non conformances are investigated and reported. Participates the evaluation and approval of these reports.
• Ensures that the manufacturing and packaging are done on qualified equipment with validated procedures. Ensures the testing of products is done by validated procedures.
• Reviewing deviations or changes in packaging, in quality control and in all the other departments of the QA system of Mylan Hungary to ensure that the records and changes have been authorized by the persons responsible in accordance with the quality system.
• Takes part in Health Authority inspections, internal and self-audits. Reviews and approves the reports or notes of audits and inspections