Objectives/purpose of job
Ensure that all required Quality systems are implemented and effectively operating in the R&D development Lab,
Ensure that all R&D project activities are carried out in compliance with the requirements of Quality Systems, FDA and other regulatory agencies up to and including Process validation.
Provide oversight for Design Management of contact lenses – from a Quality System and technical perspective
Provide Quality Support to Manufacturing Plant as required
Support Development Lab activities from a quality systems perspective,
Implement and effectively maintain compliance with regional directives and procedures across R&D activities,
Review and approve all protocols and reports for R&D equipment qualifications,
Review and approve all protocols and reports for the manufacture of Clinical Trial Materials,
Review all batch history records for clinical trial materials prior to issuing QA Release memo,
Provide Regional Quality support for all Design Control activities,
Drive and oversee all Risk Management activities for new product development,
Complete and provide Risk Management and Complaint data updates to Annual Product Quality Reviews and for revision of Design Risk Analysis and Clinical Evaluation Reports,
Review and approve all Process Validation protocols and reports for new products,
Scope of the position
Ensuring that Quality systems are effectively implemented and maintained in Waterford R&D,
Ensuring Compliance with quality standards and GMP requirements for all product/ process development activities in the R&D program of work through participation in R&D process development teams and approval of protocols.
Regional Quality support for all Contact Lens development projects in Waterford from inception to successful technology transfer / scale-up.
Risk management activities through development and product lifecycle.
Bachelor degree in Science or Engineering
Certified training in Quality Systems Requirements of FDA and ISO-13485
Certified training in Auditing of Quality Systems
Documented training in all relevant company Directive and Procedures
5+ years relevant experience in a similar industry
Excellent salary on offer. Don't delay. Mail me now firstname.lastname@example.org
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