Description
My Client, a global healthcare company based in Dublin Is seeking a senior QA specialist - Distribution to join their team.Key Responsibilities;
Maintain the companys established product Distribution QA Quality Management System, including but not limited to:
-GDP Training
-Distribution policies, guidelines and procedures
-Complaint handling
-Exception management
-Distribution Validation
-Internal Audit program
-Quality Manual
-Change Control
-Responsible for managing interactions with Central Warehouses and forwarders on behalf of the company -Perform Quality Assessments for Distribution Service Complaints
-Register and investigate product quality complaints
-Provide GDP support to both the ANI and EPD Affiliates (i.e. audits, compliance, events and exceptions); and focus on GDP/GMP Compliance in distribution and warehousing
-Select, provide GDP support and partner with Logistics/Transport Service Providers (LSP/TSP), Third Party Warehouses (TPW)
-Lead and/or participate in Supply Chain projects and/or programs, assuring GDP compliance
-Work in close collaboration with Supply Chain, Transportation, Business Process Design, Global Product Protection, in order to deliver inputs in compliance with GxP requirements
-Anti-Counterfeiting & Serialization
-Global Warehousing
-Temperature Control Product Management
-Supply Chain Optimization
-Supplier Life Cycle management (auditing, agreements, business review meetings, KPI's)
-New Product Introduction (NPI)
Education & Experience
Bachelor's degree or equivalent in technical/science, engineering, or medical fields with 7 years' experience in a pharmaceutical quality department
Key Skills
-Excellent Communication and Negotiation skills
-Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.)
-Change management -Cross-functional/cross-divisional experiences -Applicable technical knowledge
-Sound decision-making skills contributing to high levels of integrity, competence, confidence and credibility are required
-Experience dealing with international locations. -Risk management -Experienced (lead) auditor (internal,/external audits)
If you are interested in this great opportunity please contact me Anna Mooney or apply below with an up to date CV.