Job Description

Overview:
This job specification outlines the general responsibilities associated with the role of QC Specialist Sample Management . The successful candidate will function as the technical Specialist for Sample Management. Continuous Improvement, Stability, Lot Authorisation and Data Management will be key areas of focus for the role. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with the QC support function.
Key Responsibilities
• LIMS Co-ordination and Authorisation of Lots
• Stability Program Management
• Documentation – authoring, review and approval of SOPS, Sample Plans, Protocols
• SME for Investigations relating to area processes
• Process Improvement – Champion Continuous Improvement
• Management of area Change Controls and CAPA
• Co-ordination of NPI activity
• Data and Metric Management
• Equipment Management e.g. CTUs
• Delivers Training on key processes
• Audit and Inspection preparation and participation
• Represents QC Sample Management at network level
• May co-ordinate the team workload
• May act as delegate for the area Manager


Requirements

Knowledge and Experience:
• Hold a third level qualification in a Science related discipline
• Have minimum 6 years experience in Biotechnology/ Pharmaceutical setting
• Working knowledge of QC operations including Enterprise systems LIMS, CIMS, LMES, Stability advantageous

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