Sr Analyst, QA Assurance
Core
Lead investigations into product failures, market complaints, and recalls; ensure compliance with global quality metrics; coordinate corrective and preventive actions to prevent recurrence.
Role type
Senior Quality Assurance Analyst (Pharmaceutical)
Builds
Quality assurance processes and compliance reports for sterile pharmaceutical products
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Root cause analysis, CAPA management, regulatory compliance knowledge, risk analysis, trend analysis, inspection coordination
Preferred skills
Sterile product experience, Trackwise and JDE systems, electronic batch record systems
Responsibilities
Investigate deviations, market complaints, and recalls; approve investigation reports; ensure global quality metrics compliance; develop and update quality procedures; analyze trends and identify improvement opportunities; coordinate follow-up on open actions; conduct routine inspections in production and support areas.
Seniority
Senior, hands-on IC
