Compliance Assurance Specialist
5 days ago
Job Description
The role of Compliance Engineer at a leading pharmaceutical facility in the Carlow area presents an exciting opportunity to work in a dynamic and compliance-driven environment. The ideal candidate will be responsible for ensuring safety, operational efficiency, and regulatory compliance within the Engineering Department in a Good Manufacturing Practice (GMP) and sterile environment.
Key Responsibilities
- Lead investigations into deviations, failure analyses, and root cause evaluations
- Analyze engineering metrics and prepare reports to improve operational efficiencies
- Develop and review key documentation, including Standard Operating Procedures (SOPs), deviation reports, training materials, preventive maintenance schedules, and change controls
- Collaborate with cross-functional teams across IPT, Quality, Environmental Health and Safety (EHS), and Technical Engineering departments
- Ensure adherence to global policies, current Good Manufacturing Practices (cGMP), and regulatory requirements
Qualifications and Experience
- Prior experience in a GMP manufacturing environment, preferably with expertise in sterile filling processes
- Strong technical knowledge of compliance regulations, including Irish, EU, and International codes and standards
- Excellent communication, documentation, and organizational skills
- Proficiency in Microsoft Office and job-related applications
- Experience with Lean Six Sigma methodologies is highly valued
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