Product QA Specialist responsible for quality assurance of wattpad's webnovel platform. Collaborating with teams to ensure product features meet quality standards.
About the role
- QA Manager at Eupraxia managing compliance for investigational medicinal products in a clinical-stage biotech company. Overseeing quality systems, audits, and continuous quality improvement.
Responsibilities
- Ensure procedures and systems are established and maintained to ensure the Company’s compliance with ICH GXP guidelines
- Spearhead continuous quality improvement activities
- Oversee the implementation, manage the content, coordination, and execution of the Eupraxia electronic Quality Management System (eQMS)
- Define and manage the delivery of training programmes for employees via the eQMS
- Coordinate external audits, internal audits and gap analyses
- Manage the QA oversight of contract manufacturers and testing labs
- Perform rapid and agile record review and disposition activities for clinical trial material
- Lead extensive investigations with vendors and interdepartmental teams
- Drive the implementation of other quality systems, including departmental and corporate procedures
- Review CMC documents submitted to regulatory agencies
Requirements
- B.S. in a science related discipline (preferably in chemistry, biochemistry, or chemical engineering)
- 8+ years related experience in the biotechnology or pharma industry with a sound knowledge and focus on GMP operations
- Knowledge of GCP and experience with clinical operations would be an asset
- Demonstrated experience with eQMS Tools
- Experience in planning, organizing and conducting audits
- Experience in preparing for inspections ideal
- Excellent written, spoken, listening and presentation skills
Benefits
- Health insurance
- Professional development opportunities
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