Job Description:
The Quality Specialist will be responsible for the development, implementation, and maintenance of the Quality Management System (QMS) in a fully site-based role in Dublin 12.
Main Duties:
* Assist in ensuring compliance with GDP guidelines and HPRA guidelines by developing, implementing, and maintaining the QMS.
* Train all staff upon joining and implement a continuous training program for new and existing employees to promote compliance through regular training and clear communication.
* Procure authorized product classes from approved suppliers and supply them to approved customers under the Company's Wholesale Distribution Authorization.
* Support the approval of outsourced service providers and assist with transport provider route qualifications as needed.
* Review, draft, and approve documentation such as SOPs, change controls, deviations, and validation records, while ensuring accuracy in quality records and GDP systems.
* Perform initial and ongoing Bona Fide checks on suppliers and customers.
* Maintain a companywide risk management culture and ensure Quality Technical Agreements are in place and updated with suppliers, customers, and service providers.
* Manage returns by ensuring they are held securely, reported to the RP, and not made available for sale unless approved.
* Assess temperature-controlled shipments and provide quality decisions, while monitoring all temperature-controlled activities, including warehouse conditions.
* Escalate any known or suspected Adverse Drug Reactions (ADRs), serious product quality defects, or falsified medicines to the RP for reporting to authorities and authorization holders.
* Coordinate product recalls promptly and in a controlled, compliant manner.
* Support the continuity of supply while ensuring no commercial decisions compromise product quality, patient safety, or regulatory compliance.
Main Requirements:
* 3+ years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment.
* Thorough knowledge of temperature-controlled activities.
* Thorough knowledge of cGMPs/GDPs and global regulatory requirements.
* Sound awareness and understanding of pharmaceutical WDA business models, especially with regards to quality and regulatory requirements.
* Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment.
* Good verbal and written communication skills with well-structured communication and ability to present to various audience levels.