We are currently seeking an experienced Quality Specialist to join our organization in a fast-paced dynamic team. The successful candidate will be responsible for maintaining the Quality Management System processes in line with company procedures and ensuring operational compliance aligned with cGMP regulations.
The ideal candidate will have demonstrable knowledge of HPRA, EU and US GMP/GDP requirements and international guidelines governing pharmaceutical manufacturing and quality systems. They will contribute to quality activities including SOP development, document control, deviation and CAPA management, and change control processes.
Key responsibilities include providing quality support on manufacturing activities conducted at third-party sites, monitoring investigation timelines for quality issues, issuing and archiving quality documentation, and reporting out key process indicators. The successful candidate will also carry out assigned internal and external audits, aid in the investigation and evaluation of audit findings, and ensure root causes are appropriately identified and corrective actions are verified for effectiveness.
A Bachelor's Degree in a Science Related Discipline is essential, along with minimum of 3 years in a quality assurance or compliance role within the pharmaceutical industry. Strong communication skills, team orientation, detail orientation, and self-motivation are also required.