Job Description
The Quality Specialist GDP will be responsible for assisting in the provision of the company’s quality assurance functions, including the localised implementation and maintenance of the company Quality Management System (QMS). Ensuring compliance with Good Distribution Practices (GDP), for Wholesaling operations that support the procurement, storage, and supply of Authorised and Exempt Medicinal Products through the company’s core business operations of Clinical Trials Supply (CTS) and Expanded (or Early) Access Programs (EAP). Acts as the Releasing Officer for despatch activities associated with EAP product supply.
Key Responsibilities:
• Responsible for assisting the GMDP Quality Manager with the implementation maintenance and improvement of the company Quality Management System.
• Ensuring that at all times the localised implementation of the QMS is maintained in compliance with the Company’s Authorisations and Licences, GDP, and industry best practice.
• Supporting the site Responsible Persons in the delivery of the legal duties of the RP as named on the WDA.
• Perform internal audits/self-inspections as required by the internal audit/self-inspection plan.
• Support the Supplier and Vendor qualification activities ensuring (in particular) that supplier’s licenses are in place and are Bona Fide.
• Support audits of supplier and vendors, where required. Assisting with the approval of subcontracted activities which may impact upon GDP (or other relevant regulation, guidance, or best practice), including by carrying out appropriate due diligence on such subcontractors, and carrying out audits on them where applicable.
• Assist the GMDP Quality Manager with hosting & managing Client/Customer audits, & in the investigation and responses to findings resulting from those audits.
• Assisting the GMDP Quality Manager with the preparation for and hosting of Competent Authority inspections and in the investigation and responses to findings resulting from those Inspections.
• Supporting the creation & review Quality Technical Agreements.
• Supporting the Investigation of deviations and complaints; communicating outcomes with internal and external stakeholders, as appropriate.
• Undertaking the role of the Releasing Officer for products prior to shipment to Hospital and clinic centres for treatment of patients under the scope of an EAP.
• Ensuring accuracy, quality & accessibility of all required quality records, including but not limited to, investigations, self-inspection & audit records.
• Understanding & complying with all the business systems, processes and standards.
• Ensuring good relations with colleagues & 3rd parties, including Competent Authorities.
• Acting professionally & with integrity (particularly in relation to quality and regulatory matters) to act as an ambassador of the Group and its values at all times.
• Promoting a culture of Quality and continuous improvement within the Ireland facility and wider business environment.
• Maintaining accurate, well-organised records of activity, in line with Company requirements.
Competency/skill requirement and personal attributes for role:
• Third Level Qualification (essential); scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry, biology or related) (desirable).
• Impressive, demonstrable track record & skills/experience gained within similar position(s) (including quality roles and covering GMP and GDP requirements) (essential).
• Good understanding of the pharmaceutical industry, ideally including the unlicensed (or exempt) medicines sector and Investigational Medicinal Products (IMPs)
• Working Knowledge of Good Distribution Practice of medicinal products for human use (2013/C 343/01)
• Working knowledge of processes and systems used in the manufacture and distribution of licensed and unlicensed medicinal product. (desirable).
• Recent experience of, and knowledge of, working within HPRA licence requirements (desirable).
• Credible & confident communicator (written and verbal) at all levels(essential)
• Commercially astute & highly customer focused (essential)
• Strong analytical & problem-solving ability (essential)
• Hands-on approach, with a ‘can do’ attitude (essential)
• Strong organisational skills; ability to prioritise, with good time management skills(essential)
• Good attention to detail & ability to work accurately in a busy, demanding environment(essential)
• Ability to work with commonly-used IT platforms and packages(essential)
• Strong team player (essential)
For further information on this QA Specialist -GDP position please contact Gavin Kennedy at The RFT Group on 01 2302400 / gavin@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie