Senior Quality Assurance Specialist

Join our team as a Senior Quality Assurance Specialist and contribute to creating change and shaping the future of healthcare. You will be responsible for ensuring quality support to productions and projects, managing quality activities, and collaborating with suppliers and internal teams.

Requirements

• Ensures that adequate Quality support is provided to productions and to open projects / initiatives
• Ensures that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
• Ensures that quality activities for validation of new processes/ products are performed and documented according to procedures and within the defined timeline
• Write protocols and reports for validation documentation (such as process validation, test method validation, validation plan.)
• Ensures that risk analysis activities (PFMEA) are performed and documented according to procedures and within the defined timeline
• Organize meeting for risk analysis activities and write risk management documentation
• Ensures that GMP rules are known, understood, and respected on the site
• Ensure technical support to QC and laboratory department
• Collaborate with supplier quality team, manage supplier, ensure suppliers are qualified based on procedures to meet regulation requirements.
• Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
• Participates and supports internal and third-party audits / inspections
• Manages or participates to quality projects
• Provides support to complaint investigation
• Establish product related quality system documents, participate to procedure elaboration or update
• Establish testing method for products, ensure applicable gages or equipment for products testing, train inspectors and ensure inspectors can understand the testing method.
• Ensure that the release of raw materials and semi-finished products complies with procedures and regulatory requirement
• Ensure that the release of finished products complies with the requirements of procedures and regulations
• Ensures that CAPA are managed and documented according to plans and in compliance with procedures
• Ensure all quality system related change are initiated, evaluated, and ensure all actions of change control are followed up closely and closed in time.
• Ensures support to process improvement projects
• Arrange the daily work of the inspectors, provide necessary training, ensure that the inspectors meet the qualification requirements for their positions. Complete other tasks assigned by the supervisor.

Benefits

• Medical benefits
• Retirement plan
• Tuition reimbursement