Quality Compliance Officer
4 weeks ago
Key Responsibilities:
- Manage change control, complaints, and CAPA (Corrective and Preventive Actions).
- Maintain and oversee QMS processes in line with company procedures.
- Conduct and support quality tasks such as internal audits, document control, and reporting of quality indicators.
- Investigate deviations, ensure root causes are identified, and verify corrective actions for effectiveness.
- Monitor the performance of contract manufacturers and laboratories for GMP/GDP compliance.
- Review records to ensure completeness and adherence to regulations.
Qualifications and Experience:
- Bachelor's degree in Life Sciences, Biomedical, or a related field (or equivalent work experience).
- Minimum 2 years of experience in quality compliance within the pharmaceutical industry.
- Strong knowledge of cGMP, 21 CFR Part 211, and pharmaceutical regulations.
- Proficiency in MS Office.
Skills and Attributes:
- Excellent organizational and planning skills.
- Ability to manage multiple responsibilities in a fast-paced environment.
- Effective verbal, written, and interpersonal communication skills.
- Collaborative mindset with the ability to work independently when required.
For a confidential discussion about this opportunity please contact Ranait Coughlan
ranait.coughlan@collinsmcnicholas.ie
(090) 6450664 (01) 66 200 88
#J-18808-Ljbffr
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