Description
New opportunity for an experienced QA Specialist to work for a Global Biotech organization at their site in Ireland.The successful candidates will have minimum of 2 years` experience working in change control and batch record reviews for product release and must have previous pharmaceutical experience.
Ideally we would like to see candidates coming from a sterile, packaging or tablet manufacturing background
Duties
-Maintain and improve quality compliance site wide
-Provide Quality support and expertise to the IPT
-Maintain and monitor quality systems information
-Identify and implement continuous improvement opportunities for compliance initiatives
-Management of Product Quality Review (PQR) process
-Supplier Management (incl. complaints handling, analysis of quality performance and certification)
Key Accountabilities:
-Quality policies/strategy
-Focus on Quality policies/strategy in close co-operation with IPT Quality Coach and Compliance Coach
-Stay current in field of expertise
-Support development of QA/QMS policy/strategy.
-Maintain and update QA review documentation as necessary
-Generation of export certificates
Compliant Processes
-Co-ordination of complaints, including reporting, customer responses, internal investigations and metrics
-Review of data for registration filling
-Regulatory surveillance
-Maintenance of manufacturing licences
Significant Investigations
-Participate as significant investigation lead or information keeper, in close collaboration with the Principal QP, Head of Quality Operations, Compliance Coach, QP and the IPT:
-Provide support during all inspections e.g. note taker, control room support, support of compliance coach and site lead auditor
Quality Improvements
-In line with quality procedures and guidelines initiate and participate quality improvements
-Participate in a systemic approach by means of a Sub System Ownership
-Follow up on Quality Bulletins
-Supplier Management
-Liaise with Purchasing for vendor quality issues
-Approval of Itemmaster and Build of Materials (BOM) to ensure maintenance of system to ensure regulatory compliance
Regulatory Affairs
-Provide RA support to COMPANY Swords by participation in NPI
-Remain compliant with regulatory guidelines and be knowledgeable in all aspects relating to MA compliance activities initiated by regulatory authorities
EHS Responsibility
-Responsible for ensuring compliance with corporate, local and statutory EHS policies and guidelines
-Demonstrate personal commitment to EHS policies and guidelines
-Participate in incident investigations, identify true root cause and implement effective corrective actions
Interpersonal Skills
-Good team worker and collaborator
-Effective communicator at all levels
Personal Abilities
-Ability to negotiate with external service providers
-Ability to operate effectively as a constructive team player
-Ability to achieve time-phased targets