- Deviations, Change Controls and CAPA's
- Document Control
- Internal Audit
- Inspection Readiness
- Annual Product Review
- Site Master File
- Oversee relevant metrics and trending for each quality system and take action to drive the correct behaviours.
- Manage the preparation and facilitation of Corporate & Regulatory Inspections.
- Use science and risk-based methods to increase Quality Culture throughout the facility.
- Provide Root Cause Analysis support for the site
- Maintaining the core Quality Systems, and providing training on the core Quality Systems
- Leading internal audits for the site
- Development and Trending of Quality metrics for the site to ensure continuous improvement of Quality Systems and Manufacturing processes
- Liaise with colleagues to aid in harmonization of Global Quality functions and systems
- Drive projects to improve Quality Systems across site
- Liaise with Regulatory department to support GMP filings as required
- B.S. with at least 5 years of experience in a relevant functional area.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists