Our client, a leading and expanding pharmaceutical business is looking to appoint an experienced Quality Specialist professional to join their team. This position is within a Wholesale Distribution Pharmaceutical company.
The role will operate within the operational / warehouse facility of the company with a requirement to travel to other office locations to support business activities. In this position you will work within the existing Quality team and engaging with colleagues across all functions of the business, this is a broad and hands on role and the successful candidate will need to be comfortable working across all levels of the qualify function.
Key focus for the role is to;
Proactively engage with key stakeholders both internally and externally to maintain and achieve an effective supply chain of products across the business to meet customer needs;
Ensure the day-to-day management of the Quality Management System is functioning effectively at all times, maintaining a company-wide risk management culture/structure.
The Quality team is as an integral part of how the Company achieves its business goals and this broad cross functional role provides excellent opportunity for a competent and practical minded quality professional to progress within a great indigenous Irish company.
Ensure Good Distribution Practice (GDP 2013/C 343/01) and current Health Products Regulatory Authority (HPRA) guidelines ((IA-G0046) Current version =6) are adhered to covering all GDP activities performed.
Ensure that only the relevant authorised product classes are procured from approved suppliers and supplied to approved customers and are covered under the Company’s Wholesale Distribution Authorisation.
Assist in the approval of outsourced service providers and assist in route qualifications of transport providers as planned and required.
Draft new procedures required for the company and release to team on approval by the RP.
Complete relevant initial and ongoing Bona Fide checks on suppliers and customers as assigned.
Facilitate and attend regular management meetings which include Quality Reviews and Risk Management Reviews.
Reporting all temperature excursions as they arise to the RP and COO, to include temperature excursions within the warehouse, upon receipt from suppliers and on-route to customers as applicable.
Deviation Handling - Highlight deviations as they arise within the company and report and document same.
CAPAs – Identify Corrective and Preventative actions as required.
Change Control – Identify changes as needed and required and document the change control for approval of the COO and the RP.
Review and update Quality Technical Agreements as required and ensure Technical Agreements are in place with all suppliers, customers, and outsourced service providers.
Escalate any known or suspected Adverse Reactions (ADRs) and or serious Product Quality defects to your RP for onward reporting to the relevant Competent Authority and the relevant Product Authorisation holder as applicable.
Identifying trainings / re training required and reporting to management.
Observe Public Service Obligation as it applies to distribution of medicines.
Bachelor's degree in Science, Quality, Engineering or related field
3 to 5 years experience in a broad quality role in a pharmaceutical distribution or other life science organisation.
Experience in Good Distribution Practice and supply chain management is essential
FMD and Seralisation awareness.
Adheres to and follows all procedures policies and guidelines ensuring compliance with GDP and HPRA regulations and company policies, procedures, and guidelines.
Proficiency in Microsoft Office and quality management systems.
Full clean drivers’ licence and own car required for travel between sites.
Proficient verbal, written, presentation and communication skills in English.
Team player with the ability to work with all stakeholders to deliver on the objectives of the role - Ability to work effectively and co-operatively with others.
Good work ethic with a positive, can-do attitude and approach to work.
Multi-Tasker with ability to easily switch projects and changing priorities as needed.
Exceptional trouble shooting, analytical, problem-solving & root-cause analysis skills.
Possess accuracy and excellent attention to detail.
Be resilient and flexible, with the ability to cope with a change in a fast-paced environment,
Personal drive for self-development and growth.
For a confidential discussion about this opportunity please contact Gillian Nicholson
090 6450665 (01 6620088)