We are looking for a Quality Assurance (QA) Specialist.
Responsibilities :
• Responsible for the review and approval of executed batch records.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including change control, deviations, investigations and CAPA management.
• Own change control, deviation and CAPA quality system records on behalf of the department, as needed.
• Contributes to the goals within the work group.
• Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
• Initiates and revises department SOPs.
• Supports inspection readiness and acts as Subject-Matter Expert during compliance audits and regulatory inspections.
• Able to effectively multitask.
