CAPA: Responsible for identification, investigation and documentation of GPV exceptions. Work with business areas to analyze impact and ensure that appropriate actions are taken to correct and prevent reoccurrence of an issue. DOCUMENTATION & CHANGE CONTROL: Responsible for managing change control process for the GPV Quality Systems documents. Facilitate GPV review and provide feedback for division and corporate policies and procedures.
METRICS: Responsible for collection and analysis of key QS data. Issue monthly metrics reports for management review. TRAINING: Provide support to GMS departments on approval and documentation of training using ISOtrain. REGULATORY: Provides support for division, corporate and regulatory audits/ inspections of the Pharmacovigilance systems. CONTINUOUS IMPROVEMENT INITIATIVES: Participate on GPV and GMS cross-functional teams in support of business process improvements.
Skills/ Experience 3-5 years experience in Quality Systems support role, including CAPA and Document Change Control activities. Candidate must -have understanding of a Quality System and its function in an organization -have experience utilizing a variety of quality management tools -be able to make sound judgements based on facts and data -work independently and with teams -manage multiple tasks and responsibilities Knowledge of ICH/FDA/ EMA regulations and guidelines for Pharmacovigilance is desirable.
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