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QA Specialist - Responsible Person

Contract Type: Contract
Location: Dublin
Contact Name: Gavin Kennedy
Contact Email: gavin@rftgroup.ie

Job Description

QA Specialist - Responsible Person 12 months contract role
The QA Specialist - Responsible Person will be part of the Quality Systems team within Technical Operations organisation based in Dublin. The role covers the distribution aspects of the Irish Wholesale Distribution Authorisation (WDA).

Responsibilities
  • Ensure that operations do not compromise the quality of medicines by ensuring that systems are in place to monitor storage of the product through the supply chain under the control of the Dublin site WDA
  • Ensure the conditions of the Wholesale Distribution Authorisation are maintained
  • Support the preparation, implementation and on-going maintenance of the QMS systems and operational procedures, policies and other related documentation, in compliance with applicable legislation, regulations and regulatory guidance in context of GDP
  • Review and approve applicable standard operating procedures relating to GDP and advise upon the company’s standard operating procedures in relation to GDP
  • Ensure that adequate records are maintained in relation to GDP and ensure that they are accurate, legible and maintained in a secure manner
  • Have sufficient knowledge on the product distribution supply chain and its complexity
  • Participate in recall decision making and support product recalls as required under the WDA
  • Ensure any subcontracted activities which may impact on GDP are approved and that suppliers and customers are approved
  • Ensure the review, and where appropriate, preparation and regular update of Quality Agreements and Service Agreements with licensees and 3rd party contractors
  • Attend Management Reviews and Quality Council meetings to participate in the review of the effectiveness of Quality and Compliance Policy and Objectives in the context of the WDA
  • Work with local Training Co-ordinators to ensure that applicable personnel are trained in GDP and that continuous training programmes are maintained
  • Review documentation including change controls, deviations, validation documentation, SOPs and specifications relating to distribution activities
  • Ensure that customer complaints relating to GDP are processed efficiently and effectively
  • Decide on the final disposition of returned, rejected, recalled or falsified products
  • Ensure returns to saleable stock are approved
  • Ensure the potential for delays in distribution as a result of a quality issue is escalated appropriately
  • Ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
  • Keep up to date with any changes in the legislation and with on-going training as identified
  • Responsible for QA oversight of cold chain activities in markets as per WDA, in accordance with local and global GDP requirements and planning schedules
  • Assess cold chain shipments and provide corresponding quality decision on product.
  • Be contactable by the HPRA the Competent Authority at all times and provide the HPRA with the appropriate contact details
  • Support the preparation of Health Authorities inspections and provide support for regulatory submissions
    Keeping appropriate records of any delegated duties
Qualifications/ Personal Competencies
  • Bachelor's degree in chemistry, biology or a related discipline or extensive experience acting in the capacity of Deputy RP or RP
  • Minimum 3 years in international pharmaceutical and/or biotech industry with increased level of responsibility and preferably a minimum 2 years of experience in GDP
  • Ability to operate efficiently in a complex matrix organization and global environment
  • Experience in managing contractors
  • Sound awareness and understanding of pharmaceutical business, especially with regard to quality, supply chain and regulatory requirements.
  • Experience interfacing with regulatory bodies or supporting regulatory submissions is an advantage.
  • Strong verbal and written communication skills and presentation ability to various audience levels
  • Lead auditor training and experience desirable

For further information on this Responsible Person/ Senior QA Specialist position please contact Gavin Kennedy at The RFT Group on 01 2302400 / gavin@rftgroup.ie
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