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Job Description
Seeking Quality Assurance Manager to oversee Bausch + Lomb Ireland Limited's Quality Management System, ensuring compliance with EU GMP and GDP regulations.
Key Responsibilities:
- Manage QMS, ensuring fitness and making necessary changes
- Approve SOPs and Quality System documents
- Maintain Quality processes in support of BLIL authorizations
- Communicate with and represent BLIL in front of HPRA
- Provide QA expertise and manage Quality issues
- Support HPRA inspections and internal compliance audits
- Prepare and approve HPRA variations
- Review and approve Non-Conformances, CAPA, change controls, and complaints
- Ensure annual review of supplier and customer bona fides
- Review Batch records for GMP and Market Authorization compliance
- Regularly review QMS and operational procedures for regulatory compliance
- Implement Self Inspection/Internal Quality Audit program
Requirements:
- BSc (Hons) in Science or equivalent
- QP/RP qualification
- Thorough working knowledge of GMDPs and regulatory expectations
- Minimum 5 years of experience in Quality Assurance in the Health Care Industry
- Strong communication, organizational, and leadership skills
- Ability to deliver results and build relationships internally and externally
- Trained auditor
About Bausch + Lomb:
Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world.