The Quality Specialist is a key member of the quality team responsible for the maintenance of the Quality Management System processes in line with company procedures, ensuring strong operational compliance aligned with the principles and expectations of cGMP regulations.
The successful candidate must be able to demonstrable knowledge of HPRA, EU and US GMP/GDP requirements and international guidelines governing pharmaceutical manufacturing and quality systems. This is a permanent opportunity offering hybrid working once probation is passed.
Responsibilities:
Provide quality support on manufacturing activities conducted at third-party sites.
Contribute to Quality activities in a fast-paced dynamic team, including but not limited to SOP development, document control, deviation and CAPA management, and change control processes.
Monitor investigation timelines for quality issues e.g. deviation and complaints
Issuance and archiving of quality documentation.
Report out key process indicators (Document Change Control, Complaints & CAPA)
Carry out assigned internal and external audits.
Aid in the investigation and evaluation of audit findings.
Ensure root causes are appropriately identified and corrective actions are verified for effectiveness.
Support vendor qualification activities.
Lead for the training processes and procedures across the business to ensure training is administered in line with the Company Training Procedure and records are maintained.
Review records and documents for completeness and compliance with GMP/GDP requirements and internal organizational procedures.
Assist in the development, implementation, and continuous improvement of the Quality Management System (QMS).
Essential Criteria:
Bachelor's Degree in a Science Related Discipline
Minimum of 3 years in a quality assurance or compliance role within the pharmaceutical industry.
Strong, clear and concise communicator both internally and externally.
