Quality Specialist

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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