Senior QA Operations Specialist - GMP & Process Excellence

Viatris; St. Albans (VT); Presencial; USD 55.000 - 105.000; Jornada completa

Descripción de la vacante

Viatris is seeking a Senior Specialist, QA Operations to review batch records and release materials while ensuring GMP and SOP compliance. This role leads investigations, drives continuous improvement, and maintains QA documentation and training programs.

The candidate should have a Bachelor’s degree with 4+ years in a GMP environment and knowledge of cGMP, ICH, ISO/IPEC standards. Excellent MS Office skills are required.

Formación

• Bachelor's degree in a GMP-related field with 4+ years of experience or equivalent combination.
• General knowledge of quality systems for the pharmaceutical industry (cGMP, ICH, pharmacopoeia) and medical products (ISO, IPEC).
• Proficiency with MS Word, Excel, Access and Project required.

Responsabilidades

• Review in-process batch records, finished product batch records, and intermediate analytical records.
• Release intermediate materials.
• Assess manufacturing operations and process documentation for GMP compliance and SOP adherence.
• Lead evaluation and triage of events, deviations and unplanned activities impact processes or materials.
• Ensure deviations are reported and participate in investigations as required.
• Identify improvements and lead projects to continuously improve the quality system.
• Serve as QA Subject Matter Expert for elements of the manufacturing process.
• Maintain QA retain inventory and perform annual retain inspections.
• Conduct QA training and develop SOPs, QFs and training modules.

Conocimientos

Quality assurance

GMP knowledge

Quality systems

Educación

Bachelor's degree in a relevant field

Herramientas

MS Word

MS Excel

MS Access

MS Project

Descripción del empleo

Viatris is seeking a Senior Specialist, QA Operations to review batch records and release materials while ensuring GMP and SOP compliance. This role leads investigations, drives continuous improvement, and maintains QA documentation and training programs.

The candidate should have a Bachelor’s degree with 4+ years in a GMP environment and knowledge of cGMP, ICH, ISO/IPEC standards. Excellent MS Office skills are required.