Responsible for the continuous development and maintenance of the compliance status of the activities of the B& L Tampa Pharmaceuticals Organization. This includes the development of strategic and tactical goals based on evaluation of published regulatory and industry trends as well as the evaluation of the relevant quality metrics of the Tampa Organization.
1. Coordination of preparation and execution of inspections by regulatory agencies, consultants and third parties.
2. Coordination of Monthly Quality Metrics and Quarterly Management Review.
3. Continuous assessment of the Regulatory Compliance environment and its impact on B&L Tampa Pharmaceuticals, to identify appropriate continuous-improvement projects and/or CAPA.
4. Assist on activities related to any market actions, field alert reports and other regulatory actions.
5. Maintain inspections/audits CAPAs (root cause analysis, corrections, corrective action, preventive action and effectiveness checks).
6. Provide a documented review of key quality indicators to determine the need for changes in product or process specifications, manufacturing, or quality procedures
BS in Physical Science, Engineering or related field.
Special Skills: Compliance and regulatory knowledge; validation, and thorough knowledge of compounding, filling and packaging processes within the pharmaceutical industry. Ability to work independently. Ability to communicate and work well with others.
Knowledge of GxP compliance requirements.