Overview:
In this role, you will be responsible for leading investigations for Engineering and Validation deviations, along with applying process, quality, compliance, and analytical knowledge to complete the following:
1. Ensure Non-conformance are triaged within the established goals and serve as a deviation owner for minor and major deviations.
2. Initiate and manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs and EV’s, completing product impact assessments, prior occurrence reviews and authoring investigation reports.
3. Own corrective/preventative actions and effectiveness verification.
4. Update and maintain F&E procedures in accordance with site and corporate requirements. Serve as a document owner. Assist in the generation of training materials and may assist in providing training on scientific or technical aspects of the process.
5. Present investigations to regulatory inspectors and internal auditors. Provide back-room support during on-site regulatory inspections.
6. Oversee F&E audit readiness activities and track tasks to completion. Represent F&E function at Site Inspection Steering Committee meetings.
7. Generate Quality and Safety metrics for F&E function. Provide reports on quality and safety compliance.
8. Participate, when required, as a member of multidisciplinary site and multisite teams, e.g., improvements, compliance topics and change control GDEs.
9. Assist with generation and execution validation protocols and reports.
EDUCATION
B.A. /B.S. in Biology/Life Science/Engineering or the equivalent combination of education and experience.
EXPERIENCE
3+ years' experience in a similar role.
COMPETENCIES/SKILLS
1. Detailed technical understanding of manufacturing/engineering unit operations.
2. Skilled in performance of GMP production operations.
3. Regulatory knowledge and interactions.
4. Ability to lead cross-functional teams.
5. Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
6. Excellent organizational, technical writing and presentation skills.
7. Good project management skills.
8. Basic knowledge of control charting.
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