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Viatris

Global pharma selling generics and biosimilars

Quality Specialist

Regulatory & Quality (Life Sciences)Posted on Nov 13
Full-timeKomárom, HungaryNo salary listedIn-person

About the Job

Requirements

  • At least one year of work experience in quality assurance.
  • Thorough knowledge of EU Good Manufacturing Practice (GMP) guidelines.
  • Effective written and verbal communication skills in English and Hungarian, at C1 level or above in both languages.
  • Basic computer skills and experience using TrackWise, LIMS, and Empower software.
  • The qualification requirement can be met through at least one year of professional experience in quality assurance and/or quality control, a higher-level course, and/or at least a BSc degree in any discipline.
  • Ability to read and interpret documents, prepare professional reports, and conduct professional correspondence.
  • Ability to solve problems where solutions are partly standardized and require limited uncertainty or analysis; draw conclusions, follow requirements and processes, and handle partly complex problems.
  • Ability to stand and walk as required, with regular desk-based work.

Responsibilities

  • Provide independent quality assurance oversight of the site's Quality Control Laboratory.
  • Review and approve laboratory investigation records generated by the site's Quality Control Laboratory and contracted analytical and microbiological laboratories, in accordance with applicable standard operating procedures and timelines.
  • Support the evaluation and review of supplier investigations and ensure their timely approval.
  • Review finished-product quality certificates and ensure they are available to authorized personnel.
  • Coordinate elemental impurity measurements.
  • Ensure all documentation requiring approval is approved appropriately and on time in accordance with applicable standard operating procedures.
  • Ensure Good Manufacturing Practice principles are followed at all times.
  • Participate, as needed, in Good Manufacturing Practice-related training and continuing education for quality and other functional personnel.
  • Perform other duties assigned by the supervisor.

About the Company

Viatris

Global pharma selling generics and biosimilars

Viatris is a global pharmaceutical company that provides access to medicines through a diverse portfolio of branded drugs, generics, complex generics, and biosimilars, serving patients in more than 165 countries. Medicines are produced and distributed via Viatris's extensive global supply chain and commercial network, making therapies available across cardiovascular, infectious diseases, immunology, and oncology. The company differentiates itself with a large, diversified product mix, broad international reach, and a focus on access and public health rooted in the Mylan-Upjohn lineage. Its strategy combines organic growth with partnerships and acquisitions to expand patient access while pursuing sustainable operations.

Company size
10,001+
Company stage
IPO
Headquarters
Canonsburg, PA
Founded
1961

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