The QA Responsible Person is part of the Quality Sciences team within Technical Operations organisation based in Dublin. The role covers the distribution aspects of the Irish Wholesale Distribution Authorisation (WDA) and other licenses, namely the Manufacturing and Importation Authorisation for Commercial and Clinical material. The Irish Wholesale Distribution Authorisation (WDA) is managed through this role.
The QA Responsible Person is responsible for safeguarding product users against potential hazards arising from poor distribution practices in compliance with GDP Guideline 2013/C 343/01 (Good Distribution Practice of medicinal products for human Use) and acts as the Responsible Person for the Irish WDA.
Reporting to: Quality Director
- Ensure that the operations do not compromise the quality of medicines by ensuring that systems are in place to monitor the 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 the 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 enough 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 those 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
- Ensure that any additional requirements imposed on certain products by national law are adhered to, as foreseen in Article 83 of Directive 2001/83/EC
- 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 a corresponding quality decision on a product in conjunction with the QP as appropriate
- 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
Other Responsibilities: standardise with other roles
Work directly with other key departments to ensure compliance and productive working relationships. Act as primary QA technical contact point for the Affiliate Manager on GDP issues.
Work closely with other members of the Technical Operations organisation to ensure delivery of key project objectives and timelines.
Assist with troubleshooting quality issues at partner sites, when required.
Supporting regulatory submissions to ensure impacted licenses are maintained in compliance
Qualifications/ Personal Competencies:
- Bachelor's degree in chemistry, biology or a related discipline or extensive experience acting in the capacity of RP
- Minimum 5 years in international pharmaceutical and/or biotech industry with an increased level of responsibility and preferably a minimum 2 years of experience in QA and 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 regards to quality, supply chain and regulatory requirements. Experience interfacing with regulatory bodies or supporting regulatory submissions is an advantage.
- Strong mature leadership and interpersonal influencing skills
- Ability to represent the company and to negotiate at different levels contacts both internally/externally
- Strong verbal and written communication skills and presentation ability to various audience levels
- Lead auditor training and experience
For further information on this QA Responsible Person position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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