Quality Compliance Officer
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| Job Type | Permanent |
| Area | Westmeath, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2166 |
| Job Views | 384 |
- Description
- We are seeking applications for an experienced Quality Compliance Officer for our client, who is a leading pharmaceutical company based in Athlone.
Why you should apply:
This is an exciting opportunity to join a fast-growing international company whose culture centres on making lives better. You would be working within a vibrant, entrepreneurial environment alongside passionate team members who share a vision to discover, develop & commercialise pioneering technologies and solutions
What you will be doing:
Quality Assurance responsibility for document change control, complaints & CAPA management within the organization
Maintain Quality Management System processes in line company procedures
Monitor investigation timelines for quality issues e.g. non-conformance and
Issuance and archiving of quality documentation
Report key process indicators (Document Change Control, Complaints & CAPA)
Support preparations for 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 where appropriate
Review records and documents for completeness and compliance with GMP/GDP requirements and internal organizational procedures
Participate in interdepartmental initiatives for continuous improvement of procedures, processes and systems and maintain a list of compliance initiatives
Take on any further reasonable responsibilities as assigned to you by your manager
What you need to apply:
Bachelor's degree in any Life Science, Biomedical, or related field (or equivalent work experience)
Minimum of 2 years relevant experience.
Experience within the pharmaceutical sector
Good understanding of cGMP, 21 CFR Part 211, and related regulations associated with pharmaceutical product control
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
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
