Senior Quality Assurance Specialist, QMS Operations

Role Summary

Senior QA Specialist, QMS Operations responsible for the execution of day-to-day QA responsibilities for GMP manufacturing, along with building and enhancing the quality assurance systems. The role works both independently and collaboratively with Manufacturing, Quality and Facilities staff to ensure compliance with cGMPs and internal procedures.

Responsibilities

• Review and assess all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements.
• Provide inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders.
• Develop, review, and deliver training regarding QMS process or system changes.
• Support QA QMS in internal and external client audits and regulatory inspections (including but not limited to SME for QMS processes and individual records).
• Monitor and review effectiveness for QMS through trending, analysis, and metrics; report to top management and G-QMS on the performance of the KPIs and identify opportunities for continuous improvement.
• Alert senior management of significant quality, compliance, supply, and safety risks.

Qualifications

• Bachelor’s degree in biological or engineering science
• Minimum of 5 years relevant experience in a biopharmaceutical/Pharmaceutical cGMP manufacturing or similar environment
• Ability to collaborate and communicate cross-functionally
• Proven attention to detail

Education

• Bachelor’s degree in biological or engineering science