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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 received, inspected, stored, handled, redressed, released, distributed, transported, and destroyed in compliance with labelled, regulatory, and GxP standards.
Key Responsibilities:
- Implement and uphold Alcon Quality System Procedures (QSPs, MSPs, FSPs) at the local level, ensuring that local SOPs and/or work instructions are established as necessary, along with timely training assignments.
- Ensure the effective implementation of the document management system within stipulated timelines.
- 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.
- Oversee the qualification and monitoring of GxP suppliers, ensuring that processes align with Alcon Quality requirements, including those related to warehousing, distribution, and relabeling.
- Manage Environmental topics pertinent to quality assurance.
- Prepare and submit Technovigilance reports to the relevant authorities.
- Plan, conduct, 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 standards.
- 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: University degree or equivalent in a Scientific, Pharmacy, Chemistry, Biochemistry, or Engineering discipline.
Preferred Education: Pharmacy.
Experience: A minimum of 2 years in a Quality environment within the medical devices or pharmaceutical sector, with a commercial understanding of the medical device market and/or pharmaceutical industry.
Competencies: Strong skills in people management, communication, time management, problem-solving, and decision-making.
