Senior QA Consultant - Pharma/Device Manufacturing

Oxford Global Resources; Blue Ash (OH); Sur place; USD 50 000 - 65 000; Plein temps

Résumé du poste

Oxford Global Resources seeks an experienced Quality professional to conduct tactical reviews of manufacturing records, change controls and investigations, and to approve analytical data for Phase 1–3 clinical studies. The role requires a strong background in CAPA, root-cause investigations, and various validations.

Candidates should have a minimum of 5+ years in the quality organization of a Medical Device or Pharmaceutical company, and possess excellent communication and project management

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related discipline.
• 5+ years' experience in the Quality organization of a Medical Device/Pharma company.
• Knowledge of CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring, Manufacturing operations.

Responsabilités

• Review and approve manufacturing records, change controls, investigations and analytical data.
• Review and approve test methods and method validations.
• Review manufacturing validation protocols and reports.
• Document, review and batch disposition of API and drug product used in Phase 1-3 clinical studies.

Connaissances

Quality management

Analytical skills

Project management

Communication skills

Formation

Bachelor's degree in Engineering

Background in Chemistry or Biology

Outils

CAPA systems

Root cause analysis

Process validation

Software validation

Description du poste

Oxford Global Resources seeks an experienced Quality professional to conduct tactical reviews of manufacturing records, change controls and investigations, and to approve analytical data for Phase 1–3 clinical studies. The role requires a strong background in CAPA, root-cause investigations, and various validations.

Candidates should have a minimum of 5+ years in the quality organization of a Medical Device or Pharmaceutical company, and possess excellent communication and project management