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Product Quality
4 weeks ago
In this role your core responsibilities will include:
This role will suit a highly motivated professional with exceptional attention to detail to ensure compliance with all appropriate procedures, regulations and guidelines.
Responsibilities:
- Support the Regulatory Affairs Manager in the effective management and coordination of all regulatory, compliance, pharmacovigilance & medicovigilance activities relating to products placed on the Irish market by BBMIRL.
- Management of product complaints for products on the Irish market, from initial receipt through to closure, in conjunction with the company's Global Complaints Departments and in accordance with all relevant EU legislation, HPRA Guidelines and company specific Standard Operating Procedures.
- Document and maintain the complaint files for reports received.
- Prompt communication of complaints received to the Global Complaints Department and escalation of serious product complaint issues, as necessary, to the relevant people both locally and globally, within the required timeframes.
- Liaise with customers, in collaboration with the Sales teams, regarding product quality issues and also in relation to medical/technical/clinical queries, ensuring an accurate and prompt response.
- Review product complaint investigation reports and document correspondence / letters for the customers to relay the investigation results within the required timeframes.
- Assist in the co-ordination, implementation and documentation of product recalls, field safety corrective actions, quality defect investigations, compliance issues, vigilance issues and mock recalls and liaise with the relevant Global Safety/Vigilance Departments and the HPRA as required.
- Support Pharmacovigilance, Medicovigilance, Compliance and Regulatory Affairs activities as directed when required.
- Provide periodic training, as required, to all relevant personnel on the handling of product quality complaints, medicovigilance and pharmacovigilance.
- Contribute to the documentation and review of local procedures relating to product quality complaints, medicovigilance, pharmacovigilance and product recalls.
- Attend and partake in internal and external audits related to your job.
Additional:
- Fulfilment of additional administration and quality support as required.
- Back up other team members during annual or sick leave as required.
Qualifications/Requirements:
- A 3rd level qualification in a life science or pharmacy related discipline.
- Ideally a minimum of 3 years work experience in a Medical Device /Pharmaceutical Industry and a good understanding and working knowledge of GDP. Exposure to product complaints handling for medical devices and/or medicinal products would be an advantage.
- Familiarity with relevant Legislation, Regulations and Guidelines applicable in Ireland and the EU.
- Proficiency in the English language; strong verbal and written communication skills is essential.
- Ability to process technical information.
- Accuracy and excellent attention to detail are key attributes along with strong organisational skills.
- A proactive and collaborative work style and the ability to work with multiple priorities and deadlines.
- Proven interpersonal skills and the ability to communicate with people at all levels within the organisation and externally.
- Demonstrated ability to work both as part of a team and independently to determine priorities and achieve results.
- Demonstrated ability to solve problems and drive the completion of tasks.
- Proficiency in Microsoft Office required and experience with SAP an advantage.
To apply for this role please send CV to toldunne@thornshaw.com or call Linda at 01 2784703. Thornshaw Scientific is a division of the CPL Group of companies. www.thornshaw.com
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