Senior QA Operations Lead – GMP & Process Improvement

Mylan; St. Albans (VT); Sur place; USD 55 000 - 105 000; Plein temps

Résumé du poste

Viatris is seeking a Senior Specialist, QA Operations to review batch records, release materials, and ensure GMP compliance. You will lead deviation investigations, drive continuous quality improvements, and train staff on QA processes and SOPs.

The role requires a Bachelor’s degree with several years in a GMP environment and strong knowledge of cGMP, ICH, and related standards. Proficiency with MS Office is essential.

Qualifications

• Bachelor’s degree with 4 years in GMP environment or equivalent
• Strong knowledge of cGMP, ICH, Pharmacopoeia and ISO/IPEC requirements
• Proficient with MS Word, Excel, Access and Project

Responsabilités

• Review in-process batch records, finished product batch records and intermediate analytical records
• Release intermediate materials
• Assess manufacturing operations and process documentation for GMP/SOP compliance
• Lead evaluation and triage of events, deviations and unplanned activities
• Ensure deviations are reported and participate in investigations
• Identify improvement opportunities and lead QA projects for continuous quality system improvement
• Serve as QA SME for elements of the manufacturing process
• Maintain QA retain inventory and perform annual inspections
• Conduct QA-related training and develop SOPs, QFs and training modules
• Attend training classes and seminars as needed

Connaissances

Quality systems knowledge

GMP environment understanding

cGMP and regulatory familiarity

MS Office proficiency

Formation

Bachelor's degree

Outils

MS Word

MS Excel

MS Access

MS Project

Description du poste

Viatris is seeking a Senior Specialist, QA Operations to review batch records, release materials, and ensure GMP compliance. You will lead deviation investigations, drive continuous quality improvements, and train staff on QA processes and SOPs.

The role requires a Bachelor’s degree with several years in a GMP environment and strong knowledge of cGMP, ICH, and related standards. Proficiency with MS Office is essential.