Job Description
The QA Specialist/RP will work in the UK/IRE Cluster of the Distribution & Supply Chain Quality organisation.
The Responsible Person (RP), responsible for ensuring that the wholesale distribution operations are carried out in a controlled manner and for maintaining GDP compliance in all activities related to Wholesale Distribution Authorisation (WDA). The RP is also responsible for ensuring that the conditions of the WDA are in line with the Health Products Regulatory Authority?s (HPRA) Guide on Wholesaling of Medicinal Products for Human Use in Ireland.
The role includes the following:
? Accountability as responsible person for pharmaceutical distribution activities in country or country cluster
? Accountability for controlled drugs
? Primary contact for pharmaceutical-technical questions in country or country cluster
? Primary contact for local health authorities. Own relationship/communication with the local GDP Authorities, and host External and Internal inspections in Ireland
? Responsible for the execution of product launches in responsible country or country cluster
With respect to the Wholesale Distribution activities performed by, the RP shall:
- Ensure compliance to the conditions of the Wholesale Distribution Authorisation and to evolving guidelines on Good Distribution Practice (GDP) as defined by the European Commission in OJ 2013/C 343/01 and HPRA?s guidelines
- Ensure that products-related GDP activities that are delegated or contracted to other licensed sites or third party contract sites by the RP are controlled through agreements and where appropriate audits.
These activities include:
? Ensuring that a quality management system is implemented and maintained
? Focusing on the management of authorised activities and the accuracy of and quality of records
? ensuring that initial and continuous training programs are implemented and maintained;
? coordinating and promptly performing any recall operations for medicinal products;
? ensuring that relevant customer complaints are dealt with effectively;
? ensuring that suppliers and customers are approved;
? approving any subcontracted activities which may impact on GDP;
? ensuring that self-inspections are performed at appropriate regular intervals following a prearranged Programme and necessary corrective measures are put in place;
? keeping appropriate records of any delegated duties;
? deciding on the final disposition of returned, rejected, recalled or falsified products;
? approving any returns to saleable stock;
? ensuring that any additional requirements imposed on certain products by national law are adhered to.
As the Responsible Person should:
Own Quality and Technical Agreements, may lead or support Supplier Audit and Quality review meetings. Manage daily interaction and communication flow with CDO(s). Own final disposition on returned, rejected, recalled or falsified products; authorise and manage product rework and destruction with the support and approval of GMP groups such as QA and QP. Responsible for oversight of qualification of new CDOs.
? Responsible for Document management, training management and implementation of any and all required local and global Quality management systems
? Assure the Management System (QMS) in country or country cluster is compliant with the European and national regulations, and with Global QMS, including SOPs, Change Control, CAPA, Record management, internal audit, mock recall, suspect counterfeit handling and management review systems.
? Ensure QA oversight of Distribution partners in country or country cluster, including managing QA audit, QTAs, product launches, and qualification of new Distribution partners.
? Provide Quality support to the local operation, for both the existing business and the new product launches. Develop close relationships with other internal functions e.g. Regulatory Affairs, Global Pharmaceutical Technology, Materials Management, Supplier Relationship Management, Supply Chain, both at a local and global levels.
? Support of projects within LOC QA, including launch/expansion in country/country cluster
? Is accountable for all quality KPIs for the country or country cluster as required.
? As an active member of Global QA Community, contribute to develop and strengthen global quality management systems, and provide flexible support to business both at the country and country cluster level and global level.
Education and Experience Requirements:
? Meets qualifications to be a Responsible Person (RP) in Ireland
? Thorough detailed understanding of quality systems, GMP and GDP as expressed in EC OJ 2013/C 343/01
? Minimum Bachelor?s degree in pharmacy, chemistry, biology or a related discipline
? Extensive experience working in a QA role
? Significant experience working in the biopharmaceutical industry
? Excellent interpersonal skills and professional skills to interact with contractors
? Must be able to prioritise and multitask in a challenging environment
? Understands regulations pertaining to licensing, import/export, scheduled/controlled drugs, and transportation requirements.
? Experience in handling inspections from local authorities
For further information on this QA Specialist/RP position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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