On behalf of our client, we are currently recruiting for a Quality Specialist /Responsible Person for a 12 month fixed term contract. There is potential for permanency. Flexibility to work remotely/hybrid with regular onsite attendance at client locations. Applications for reduced hours may also be considered.
Key Accountabilities/Responsibilities:
• Support the Quality team with the maintenance of the Company’s QMS;
• Ensuring compliance to ISO 9001 and GMP requirements and internal procedures;
• Managing the internal QMS such as raising non-conformances, change controls, CAPAs, quality complaints etc. as required
• Maintenance of the supplier management system, including completion of supplier evaluations, assessment and repeat evaluations according to internal procedures;
• Ensuring compliance to Internal Audit schedules, executing internal audits;
• Ensuring continual improvement, maintenance of internal KPIs
• Liaising with fellow team members and ensuring awareness to changes to QMS as appropriate.
Specific to role of Responsible Person for nominated clients:
• Ensure compliance with the requirements of EU GDP guidelines and other relevant guidelines including HPRA local guidelines
• Experience working under MHRA GDP requirements would be an advantage
• Ensure the safety, quality and traceability of products are maintained through the entire supply chain
• Ensure that the conditions of the Wholesale Distribution Authorisation are met and that all medicinal products wholesaled, are received, stored, transported, and delivered under strict GDP conditions
• Ensure that all bona fides of suppliers /customers/service providers are conducted and maintained in a timely manner
• Ensure self-inspections and audits are carried out as per written audit schedule
• Act as the main point of contact and be legally responsible to the HPRA and advise HPRA of any changes in a timely manner for those WDA’s where you are the nominated RP
• Lead regular management review meetings with Senior management teams
• Coaching/Mentoring Quality professionals/Deputy RPs
• Ensure patient safety and product safety at all times
Requirements
· This role requires a B.Sc. in a Life Science subject and 5+ years of Quality and GDP expertise, including previous experience named as an RP on a WDA in Ireland.
· Minimum of 5 years experience in Quality and GDP
• A minimum of one year’s experience named as an RP on a wholesale distribution authorization in Ireland
• Thorough working knowledge of EU GDP requirements
• Ability to represent clients across different levels of the organization, including dealing with competent authorities
• Experience hosting client and competent authority is essential
• Experience and comprehensive knowledge of ISO 9001 standard, GMP and GDP guidelines
• Experience performing audits would be an advantage
• Strong interpersonal and communication skills with proven ability to influence people both internally and externally to achieve objectives.
• Ability to project manage and multi-task workload
• Excellent attention to detail, with client satisfaction an integral part of your work ethic
• Maintain client confidentiality and observe discretion at all times
• Strong work ethic
• Experience with EQMS implementation is desirable but not a requirement
• Ability to work with different clients and different product portfolios
For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail [email protected]
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
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