I'm currently recruiting for a Quality Officer role with on of our Athlone based clients. This is a permanent role with strong salary and benefits package, and a hybrid working model.
Key Responsibilities
- Quality Assurance responsibility for change control, complaints & CAPA management within the organization
- Maintain Quality Management System processes in line company procedures
- Monitor and support the completion of quality tasks e.g. change control and CAPA actions, internal audits, etc.
- Document control, including issue and archiving of documentation
- Report out key process indicators (Change Control, Deviations, Complaints, CAPA, etc.)
- Aid in the investigation of deviations
- Ensure root causes are appropriately identified, trended and corrective actions are verified for effectiveness
- Monitoring the quality performance of contract manufacturers and laboratories
- Review records for completeness and compliance with GMP/GDP requirements and internal procedures
- Take on any further reasonable responsibilities as assigned to you by your manager
Qualifications / Experience
- Bachelor's degree in any Life Science, Biomedical, or related field (or equivalent work experience)
- Minium of 2 years’ experience quality compliance experience within the pharmaceutical industry
- Good understanding of cGMP, 21 CFR Part 211, and related regulations associated with pharmaceutical products
Attribute
- Must possess excellent organizational skills, planning, scheduling, the ability to follow and help drive complex processes, procedures and systems
- Willingness and capability to handle multiple responsibilities that are required in a start-up organization
- High proficiency in MS Office
- Must maintain a high level of professionalism
- Must have effective verbal, written and interpersonal skills
- Ability to work in collaborative and independent work situations and environments with minimal supervision
