Senior Supplier Quality Specialist
Dublin City Centre
Senior Supplier Quality Specialist - Dublin city. In this capacity you will be responsible for driving the supplier complaint process and defining any impact on the company. This role will be the quality point of contact regarding supplier complaints related to the manufacturing site(s) impacted. Key responsibilities include: • Ensuring urgency and ownership of supplier quality issue resolution. • Single point of contact in local Quality, driving resolution of quality issues together with the supplier. This includes customer complaints and non-conformances. • Collaborating with key quality and business partners to ensure full investigation of suppliers’ quality issues. • Understanding impact of supplier quality issues to stakeholder via go-see GEMBA's on site. • Ensuring feedback to stakeholders on supplier issues. • Work with key stakeholders to support supplier quality agreements, support contract creation and sustain supplier relationship building. • Communicate and escalate investigation results and facilitate failure investigation decision process. • Responsible for ensuring CAPA implementation based on the information given in the supplier investigation. • Participate in periodic Quality management system review and may attend audits at suppliers to verify that process capability requirements are maintained. • Supports continuous improvement initiatives for suppliers’ complaints, • Supports complaint investigation process in internal and external regulatory inspections. • Ensures compliance with QMS and applicable global regulations and requirements regarding complaint investigation. • Establish and/or improve monitoring measures for key elements related to quality goal attainment. • Dublin representative in the process group in the Supplier Complaint process. • Support EMSQ with local perspective on supplier performance and taking active part in global supplier performance initiatives. Interested applicants should have: Minimum third-level qualification in Science (Pharmacy, Chemistry), or Engineering, or equivalent. Minimum 5 years' experience in pharma in a QA/QC environment. Thorough knowledge of cGMP and relevant regulatory requirements is a must. Excellent communication skills a must. Demonstrated ability to implement continuous improvement methods to improve quality and operations performance. Six Sigma / Lean experience or qualification an advantage. Thorough understanding of processes within deviation, CAPA, change control etc.
47 days ago