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