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Compliance Officer - Supply Chain, Loughrea
Location: Loughrea, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
b3512c0e33fb
Job Views:
2
Posted:
24.04.2025
Expiry Date:
08.06.2025
Job Description:
To proactively lead and manage the day-to-day Quality Assurance function across Chanelle Pharma’s Supply chain departments (Procurement, Planning and Warehousing). The role will be responsible on all aspects related to quality compliance and execute tasks on quality documents such as change control, deviations, CAPA, FMEA whilst ensuring compliance to the Quality Management System. Location: Onsite in our Loughrea facility (5 days per week).
Responsibilities:
1. Be the overall compliance owner in the assigned functional area.
2. Report any issues or gaps identified and take appropriate actions and points of escalation.
3. Ensure all quality reports are written and approved within the required timeframe by the department.
4. Create, lead & review process investigations and risk assessment documents to ensure appropriate documentation with relevant corrective actions, if necessary.
5. Raise, investigate, and review compliance documents e.g., Change Controls, Deviations, SCARS, Reject Notices, and CAPAs.
6. Conduct routine Quality Audits of the department to ensure compliance and proactively resolve issues.
7. Provide and update existing Quality Procedures such as Standard Operating Procedures (SOP’s) in line with GMP regulations.
8. Provide compliance training and coaching within the supply chain department.
9. Be present on GMP and VM walks and take appropriate actions from these activities.
10. Support or lead Quality based projects within the department including working as part of a multidisciplinary team as required.
11. Participate in self-inspections, internal and regulatory audits and ensure necessary corrective actions are implemented.
12. Assist the Procurement team in the creation of Approved Supplier Packs.
13. Support and participate in Change Control meetings and the monthly ‘Quality Management & Review’ meeting.
14. Any other duties assigned by the direct Line Manager.
Education & Experience:
Bachelor’s degree in quality or science-based discipline. Minimum of 2-4 years’ experience in a GMP manufacturing environment with working knowledge of EU GMP and US FDA Guidelines essential. Experience working in pharmaceutical preferred; however, medical device industry experience will also be considered. Excellent Report Writing and IT Skills. Demonstrated hands-on experience of delivering a best-in-class QA function in a similar role.
Skills & Competencies:
1. Excellent Communication and Interpersonal skills.
2. Analytical, Methodical and structured approach to organising work.
3. Process Improvement Mindset essential.
4. Ability to manage multiple critical priorities.
5. Exceptional Team Playing skills with the ability to manage multiple stakeholders.
6. Displays flexibility and shows willingness to learn and do that little bit extra.
7. Working knowledge of Quality Risk Management regulations and best practices.
Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.
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