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Compliance Officer

Company Name:
Career Development Partners
REQUIRED SKILLS:
2+ years of experience in a pharmaceutical related field;
Knowledgeable in FDA or other governmental regulator body audits, root cause analysis, CQA (Certified Quality Auditor);
Knowledgeable in analytical or scientific software, compliance software, EtQ FDA cGxP, Compliance software for Life Sciences, Governance, Risk, and compliance GRC software;
Excellent interpersonal, communication and problem solving skills.
EDUCATION: 4-year degree required in a Scientific or Engineering discipline.
DESCRIPTION:

Identifying and correcting any cGMP inadequacies in order to support manufacturing operations and maintain a high level of internal and external audit readiness and Regulatory Compliance;
Working with the Compliance Management Team to support and maintain the Quality Systems in place at the Production Unit from a local, regional and global perspective;
Reviewing investigations and helping to define necessary corrective actions;
Assisting in the coordination and collection of data for all internal and corporate audits;;
Providing support to Regulatory Authority inspections, Field Alert Report tracking and material review management;
Supporting the compilation of Annual Product Quality Reviews.

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