Somerville, New jersey
Contract Auditor Job Opening in Somerville, New jersey - Qualifications:
Accredited University Degree
2 years minimum of experience in auditing or QM
5 years minimum of experience in the pharmaceutical industry
Skills:
Excellent interpersonal communication and problem solving skills
Ability to focus on details and organize tasks while adhering to defined timelines
Experienced in conduct of various types of audits (site audits, inspection readiness assessments, vendor audits, document audits, etc.), including audit planning, performance, reporting and follow-up.
Experienced in all aspects of Quality Management including QM Plans and QSP development
Knowledge of all laws, regulations and guidelines applicable to the task assigned, such as ICH-GCP, GMP, GLP, FDA CFR, ISO 9001, the Engage Auditing Guideline, local regulations
Understanding of all processes and procedures to be followed (QSPs)
Responsibilities:
Conducts all project-related tasks (planning, performance, reporting and/or follow up) assigned by the Program Director; schedules appointments as necessary for the conduct of such activities
Discuss findings with Program Director and writes the project report for approval by the Program Director
Job Type: Contract
Job Location:
Somerville, NJ
Required experience:
Auditing / Quality Management: 2 years
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