Principal QA Specialist — GxP & Audit Expert

Jobs2Web; Colbert (GA); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Boehringer Ingelheim is seeking a Principal Specialist, QA to support the GI site in ensuring GMP/GxP compliance for regulatory submissions. The role collaborates with the Site Quality Head to prepare for inspections and to maintain quality across Deviations, Investigations, CAPA, and change controls.

The ideal candidate brings 5+ years in QA/audit within pharma, strong cross-functional collaboration, and excellent communication in English and local language.

Qualifikationen

• BA/BS in chemistry, life sciences, pharmacy or related field with minimum five years of professional experience.
• Three years of experience conducting audits in pharma/biotech or related industries.
• Experience auditing in pharmaceutical/biological sectors and cross-functional collaboration.
• Excellent verbal/written communication in the local language and English.
• Strong knowledge of GxP and QA/documentation practices.
• Proficiency with MS Word, Excel, Outlook for QA activities.

Aufgaben

• Supports Deviations, Investigations, CAPA, change controls and their impacts.
• Participates in QS process harmonization and acts as GIQA project representative.
• Ensures GMP compliance during project development phases at local level.
• QA review of GMP study and batch production documents for registrations/validation.
• Organizes and participates in GxP inspections and audits.
• Supports CAPA follow-up and conducts supplier audits.
• May lead less complex audits and act as LMSO for supplier qualification.
• Reviews QA documentation and approves procedures covering GI GxP activities.
• Provides training on regulations, guidelines, and SOPs as required.
• Identifies quality improvements and reports quality KPIs to management.

Kenntnisse

Auditing experience

Cross-functional work

GxP knowledge

Communication skills

MS Office

Project teamwork

Ausbildung

BS in chemistry or life sciences

Jobbeschreibung

Boehringer Ingelheim is seeking a Principal Specialist, QA to support the GI site in ensuring GMP/GxP compliance for regulatory submissions. The role collaborates with the Site Quality Head to prepare for inspections and to maintain quality across Deviations, Investigations, CAPA, and change controls.

The ideal candidate brings 5+ years in QA/audit within pharma, strong cross-functional collaboration, and excellent communication in English and local language.