Quality Specialist

5 days ago

Dublin, Dublin City, Ireland Cpl Full time

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 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 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 or e-mail

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1

#LI-LD1

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