Quality Assurance Support Analyst
hace 2 semanas
Support and maintain the processes and procedures needed for an effective Quality Management System, covering all necessary GxP, Quality regulations and standards.
- Support for all incoming products are received, inspected, stored, handled, redressed, released, distributed, transported and destroyed according to labelled, regulatory and GxP requirements.
- Support the implementation of Alcon Quality System Procedures (QSPs, MSPs, FSPs) at local level and ensure local SOPs and/or work instructions are in place if needed, including adequate and timely training assignments. Ensure document management system is followed.
- Support the continuous improvement by management of local deviations through the identification, investigation, root cause determination, documentation, follow up and closure of Corrective Actions. Support Escalations as required.
- Contribuite to GxP suppliers are properly qualified, monitored and processes are compliant with Alcon Quality requirements (e.g. warehouse, distribution, redress/relabeling).
- Support the audits required as part of the self inspection program and external audits of GxP suppliers. Support the preparation of external Quality System audits by Notified bodies and Health Authorities as needed.
- Ensure that an adequate and effective Change Control process is in place.
- Support the manage of complaints, recalls, counterfeits and product tampering according to the Alcon Corporate Quality Manual and the Escalation if required.
Experience Qualifications
- No experience required
Minimum Education
- University degree qualification or equivalent in Scientific or Engineering discipline
Lengauage Skills
- Medium-High level in English as second language (verbal and written)
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