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Quality Assurance Specialist
hace 2 meses
Role Overview: The Quality Assurance Specialist is accountable for ensuring that all incoming products are properly received, examined, stored, managed, reconditioned, released, distributed, transported, and disposed of in accordance with regulatory standards and Good Practice (GxP) requirements.
Key Responsibilities:
- Implement and uphold Alcon Quality System Procedures (QSPs, MSPs, FSPs) at the local level, ensuring that local Standard Operating Procedures (SOPs) and/or work instructions are established as necessary, along with timely training assignments.
- Oversee the effective implementation of the document management system to ensure compliance and timeliness.
- Drive continuous improvement initiatives through Change Controls and manage local deviations by identifying, investigating, determining root causes, documenting, following up, and closing Corrective Actions. Escalate issues as needed.
- Ensure that GxP suppliers are adequately qualified, monitored, and that their processes align with Alcon Quality standards (including warehouse, distribution, and relabeling activities).
- Manage Environmental responsibilities and ensure compliance with relevant regulations.
- Prepare and submit Technovigilance reports to the appropriate regulatory authority.
- Plan, execute, and report on audits as part of the self-inspection program, ensuring that audits of GxP suppliers are conducted as required. Facilitate and report on external Quality System audits by Health Authorities as necessary.
- Collect and report Key Quality Indicators in line with Corporate QA requirements.
- Maintain up-to-date knowledge of local and international regulatory and legislative requirements to provide technical support on all quality-related matters.
Qualifications:
Minimum Education: A university degree or equivalent in a Scientific, Pharmacy, Chemistry, Biochemistry, or Engineering discipline.
Preferred Education: Pharmacy.
Minimum Work Experience: A minimum of 2 years in a Quality environment within the medical devices or pharmaceutical industry, with a solid understanding of the commercial landscape.
Competencies: Strong people management, communication, time management, problem-solving, and decision-making skills are essential for success in this role.
