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GCP/QA Auditor
Shionogi USA is the US subsidiary of a leading Japanese pharmaceutical company, Shionogi & Co., Ltd. We are in the unique position of having the financial backing and the research capabilities of a well-established, leading Japanese pharmaceutical company, matched with the entrepreneurial spirit of a start-up company. Our clinical development activities are increasing and we need a talented GCP Auditor to join our team – a group of talented professionals whose experience comes from a wide range of US pharmaceutical companies.
Responsibilities
• Audit clinical trials including clinical investigator audits, clinical vendor audits, directed process audits, due diligence and other special audits and assessments to assess quality level and compliance with applicable GCP regulations.
• Communicate audit findings and recommendations for corrective actions.
• Create formal audit reports and assign associated corrective action plans.
• Ensure effective closure, by working with auditees to ensure comprehension, development and execution of corrective/preventive action with regards to any non-conformities cited during audits.
• Develop/modify audit checklists as regulatory requirements change.
• Conduct and support benchmarking activities.
• Participate in development of process improvement strategies and tools.
• Maintain required knowledge of applicable regulations and government, industry and company GCP standards and their interpretations by participating in industry trainings, workshops and discussion groups.
Qualifications
• BA/BS in the life sciences required
• At least 3 years of relevant industry experience, including at least 2 years of GCP audit experience.
• Thorough knowledge of ICH Guidelines and GCP including regulatory requirements for the conduct of clinical development programs.
• Familiarity with GLP and database audit practices a plus.
• Excellent oral, written and verbal communication skills.
• Appropriate technical skills in GCP compliance.
• Proven interpersonal skills.
• Ability to travel at least 50% of the time.
Shionogi USA offers a dynamic environment, a competitive compensation package and a comprehensive benefits program. For consideration, please email your resume/CV to recruiting@tds.net. . We are an Equal Opportunity Employer.
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Position Type:
Employee
Ref Code: 01 |
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