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Details

PQV Combination Products Analyst


Reference:SMC37725 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: IT Analyst

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Perform high-volume end-to-end complaint handling activities, including intake, triage and review of the event reported, determination of MDR reportability, recovery of field samples for evaluation, determination of Priority/Non-Priority, and QP notification to LOC.
• Perform MDR evaluations and document written justification to support reportable and non-reportable regulatory decisions.
• Monitor complaints for new malfunction events that may require inclusion in the malfunction description list.
• Ensure uniform and timely management of complaint and MDR records from receipt to closure.
• Ensure investigations are accurately assessed for risk prioritization and performed per procedures, standards, and regulations.
• Evaluate complaints to determine if the QTL’s or ULC’s have been exceeded, assess the level of investigation required, and assign to the applicable site for investigation.
• Back-up Product Quality Vigilance Investigation Support (PQVIS) personnel to support increased volume of complaints.
• Support internal and external audits and inspections; ability to communicate regulatory and process positions as an SME during regulatory inspections.
• Provide product workflow leadership to PQV peers to ensure consistent and fully understood End-to-End complaint management process.
• Ability to allocate and balance competing priorities in driving business results.
• Works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools. Participates and/or leads special projects.
• Develop and deliver training for colleagues and stakeholders on the complaint handling process, product specific training, and complaint handling system updates/changes.
• Exhibit strong ability to collaborate and influence Business Partners to ensure appropriate complaint handling and improved complaint management processes.
• Evaluate and review complaint data trends, KPI trends, and product report trends.
• Support the development, revision, and / or maintenance of applicable documents (WI/Job Aids/SOPs.

Education & Experience

• Related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related highly regulated industry.
• Knowledge of medical safety environment and regulation.
• Bachelor’s degree or Master’s degree (preferred) in technical, scientific, or engineering disciplines required. Biomedical Engineer, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.



If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480