An important role in the QA department, reporting directly to the QA Compliance/Qualified Person, the Compliance Officer will be responsible for issue and review of customer quality complaints, product quality review and provide support to QP / QA Manager / Head of Quality. Responsibilities may also entail the co-ordination and the execution of different Compliance activities with the relevant departments within the Chanelle Group.
Key Responsibilities:
1. Issue, conduct and review investigations of Quality Customer Complaints reported.
2. Approving BOMs and revision to BOMs.
3. Approving artwork change requests as and when required.
4. Review of all specifications and process against registered documents.
5. Assist in the delivery of GMP Training.
6. Assist in the conduction of Gemba Walks.
7. Review and approval of manufacturing and packaging work orders.
8. Conduct and assist in customer and regulatory audits.
9. Generation of associated procedures.
10. Communicate customer requirements to regulatory departments and follow up.
11. Support customer and regulatory audits and follow through with CAPA responses as appropriate.
12. Preparation and maintenance of product quality reviews (PQR) as per schedule.
13. Provide technical support to the MAH for New Product Introductions and existing Products.
14. Preparation and maintenance of Technical Agreements.
15. Preparation and review of Quality Risk Assessments.
16. Support a vendor management team when required.
17. Contributing to the overall improvement of the company from a Quality/GMP perspective with an emphasis on continuous improvement of the quality system.
18. Preparation and review of Standard Operating Procedures, preparation and review of investigation reports and risk assessments.
19. Any other duties assigned by the Head of Quality / QA Manager / QP.
Qualifications:
1. Bachelor’s degree in a Science related discipline.
2. Desirable a minimum of 3 years’ experience of working in a similar Quality Assurance related role in the Pharmaceutical Industry.
3. Knowledge of EU quality-related pharmaceutical regulations.
4. Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.
5. Ability to build relationships and collaborate with others is vital.
6. Strategic decision-making within the business as an influencer.
7. A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
8. Demonstrated ability in prioritizing key initiatives, driving growth and setting targets and KPIs to monitor performance.
9. Positive and proactive person who is energized by having great responsibility.
10. Practical, action-orientated approach to managing priorities and teams.
11. Strong computer skills in MS Office.
Chanelle Pharma
Dublin Road, Loughrea,
Co Galway, Ireland.
#J-18808-Ljbffr