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:

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Support the Quality team with the maintenance of the Company's QMS;

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Ensuring compliance to ISO 9001 and GMP requirements and internal procedures;

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Managing the internal QMS such as raising non-conformances, change controls, CAPAs, quality complaints etc. as required

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Maintenance of the supplier management system, including completion of supplier evaluations, assessment and repeat evaluations according to internal procedures;

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Ensuring compliance to Internal Audit schedules, executing internal audits;

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Ensuring continual improvement, maintenance of internal KPIs

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Liaising with fellow team members and ensuring awareness to changes to QMS as appropriate.
Specific to role of Responsible Person for nominated clients:

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Ensure compliance with the requirements of EU GDP guidelines and other relevant guidelines including HPRA local guidelines

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Experience working under MHRA GDP requirements would be an advantage

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Ensure the safety, quality and traceability of products are maintained through the entire supply chain

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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

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Ensure that all bona fides of suppliers /customers/service providers are conducted and maintained in a timely manner

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Ensure self-inspections and audits are carried out as per written audit schedule

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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

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Lead regular management review meetings with Senior management teams

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Coaching/Mentoring Quality professionals/Deputy RPs

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Ensure patient safety and product safety at all times
Requirements
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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.
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Minimum of 5 years experience in Quality and GDP

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A minimum of one year's experience named as an RP on a wholesale distribution authorization in Ireland

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Thorough working knowledge of EU GDP requirements

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Ability to represent clients across different levels of the organization, including dealing with competent authorities

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Experience hosting client and competent authority is essential

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Experience and comprehensive knowledge of ISO 9001 standard, GMP and GDP guidelines

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Experience performing audits would be an advantage

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Strong interpersonal and communication skills with proven ability to influence people both internally and externally to achieve objectives.

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Ability to project manage and multi-task workload

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Excellent attention to detail, with client satisfaction an integral part of your work ethic

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Maintain client confidentiality and observe discretion at all times

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Strong work ethic

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Experience with EQMS implementation is desirable but not a requirement

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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 or e-mail ******
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment.
Part of the CPL Group.

Tel:
#LI-LD1
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