Head of Quality Operations/Responsible Person

On behalf of our client, a Dublin based pharma company, we are currently recruiting for a Head of Quality Operations & Responsible Person (RP) . This role is based in the Dublin site and will be hybrid.

Oversee and assure Quality of the in-market quality GDP related operations in Europe CIS region in compliance with local regulations. Build the important interface between company entities and national competent authorities. Fulfils the role of Responsible Person. Assure the maintenance of the associated GDP (WDA) and GMP (MIA) authorizations.

Responsibilities

Quality Management & Assurance

·               Provides direction and leadership to direct reports and other key QA Managers to enhance compliance of GMP/GDP systems in Europe & CIS region.

·               Assures that the Quality Team complies with company policies and the QMS.

·               Is responsible for the overall site GDP compliance in terms of HPRA requirements, company policies, procedures and all other applicable regulations and guidelines.

·               Is accountable in conjunction with the Qualified Person for Pharmacovigilance  (QPPV) for the overall site GMP compliance in terms of HPRA requirements, company policies, procedures and all other applicable regulations and guidelines.

·               Attends the periodical Quality Management Review meetings for monitoring trends in quality parameters, Deviation and Change Control; presenting recommendations to the Pharma Affairs management to maintain process under control and/or to further improve the process.

·               Presents regularly performance reviews against measures relating to the Pharma Affairs GDP related operations objectives at periodically held Quality Operations meetings.

·               Ensures self-inspections are performed in adherence with an approved schedule at defined intervals and that necessary corrective actions are implemented.

·               Holds overall responsibility for reporting and investigation of non-conformances and identification of CAPAs for continuous improvement.

·               Approves change requests, risk assessments and action plans.

·               Keeps up to date with any changes in the legislation and work seamlessly with  personnel as it relates to Quality requirements for Europe CIS.

·               Ensures that any additional requirements imposed on certain products by national law are adhered to, as foreseen in Article 83 of Directive 2001/83/EC

·               Ensures that accurate records are kept and maintained in a secure manner as per Good Documentation Practice.

·               Oversees the management of eQMS, LMS, QDocs, and SharePoint.

·               Reviews/Approves Standard Operating Procedures and all master quality documents in relation to the operation of the GDP/GMP licences in the region

·               Vendor Management: Monitors operations of the Logistic Service Providers.

·               Oversees the qualification of suppliers/service providers in the region

·               Ensures appropriate transport requirements and methods for cold chain, ambient and hazardous product with the Logistic Service Provider

·               Ensures that LSP/distributor audits and inspections are performed and monitors CAPA plans.

·               Keeps oversight on supplier and customer bona fides.

·               Approves any subcontracted activities which may impact on GDP.

·               Ensures that Quality/Technical/Service Agreements are in place with all GDT related suppliers, service providers and contractors in Ireland and EU Cis markets

·               Organises independent internal and external audits and inspections for assigned vendors as per the audit and self-inspection schedules.

·               The RP is responsible for ensuring that the conditions under which the licence was granted have been, and are being, complied with; and ensuring that the quality of medicinal products handled by the licence holder is being maintained in accordance with the requirements of the marketing authorisations applicable to those products.

Requirements:

·      Pharmacy or Analytical Science or related

·      10 years’ experience in Pharmaceutical Industry

·      Ability to work in a complex matrix team environment and with both internal and external partners

·      Currently listed as Responsible Person (RP) on Irish licence

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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