DescripciónDescriptionPerform one or more of the following duties and responsibilities in support program under minimal supervision.
FUNCTIONS
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
Requisitos RequirementsDoctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
Educational background in Life Science and/or Engineering.
• Perform Trackwise system queries, deviations
• Participate in triage process
• Perform oversight of the process and procedures/GMP tasks
• Manage Change Controls and deviations for review and approval as QA contact
• Work with operations to resolve basic compliance discrepancies
• Knowledge in Validations and Laboratory area and equipment
• Strong organizational skills, including ability to follow assignments through to completion.
• Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
• Microsoft Office spreadsheet and application skills and p
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