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About the role
Key responsibilities & impact- Prepare and execute internal self-inspections and supplier audits and issue reports.
- Follow up on post audit action tracking & progress.
- Assisting in implementing Internal Audit plans for all Grifols manufacturing plants within North America.
- Assisting in implementing Supplier Audit plans for all Grifols manufacturing plants within North America.
- Trends, analyses, and reports on quality data to improve product and process Quality for all Grifols plants; develop actions for improvement based on data analyses.
- Peer Review and approval of Audits Reports.
- Provide support prior, during and post inspections for External Regulatory Inspections, Customer Audits and Corporate Internal Audits.
- Ensures the corrections of findings, risks and improvements are promptly and thoroughly incorporated into the quality systems.
- Keeping abreast of industry standards and regulations.
- Contribution to the continuous improvement of the Quality Management System is required.
Requirements
What you’ll need- Minimum Bachelor’s degree in a scientific discipline.
- Minimum of 8+ years related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing.
- ASQ Certification as a Quality Auditor, Manager or Engineer a plus.
- Superior knowledge of U.S. cGMPs and FDA guidance.
- Superior knowledge of EU GMPs, Annexes and ICH Guidance’s and International Standards (Risk Management, ICH 8, 9, 10)
- Knowledge of drug product manufacturing, packaging, laboratory, and warehousing operations.
Benefits
Comp & perks- Competitive salary
- Health insurance
- Retirement plans
- Paid time off
- Professional development opportunities
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
internal self-inspectionssupplier auditsquality data analysisquality management systemGMP auditingrisk managementdrug product manufacturingpackaging operationslaboratory operationswarehousing operations
Soft Skills
communicationanalytical thinkingattention to detailproblem-solvingteam collaborationreport writingorganizational skillscontinuous improvement mindsetpeer reviewaction tracking
Certifications
ASQ Certification as a Quality AuditorASQ Certification as a Quality ManagerASQ Certification as a Quality Engineer