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SENIOR GCP AUDITOR / QA MANAGER H/F
Référence :

P70030

Lieu :

Switzerland

Descriptif :



Job type: Fulltime, permanent

Salary: Senior GCP Auditor: up to CHF 120,000/ year ; QA Manager: Up to CHF 140,000/ year

Position Overview

The Senior GCP Auditor / QA Manager will be a critical team member who contributes to the implementation GCP audit programs and clinical compliance oversight.
Some of the Job Responsibilities:
• Lead domestic and international Investigative Site Audits to ensure compliance to the Code of Federal Regulations, the International Conference of Harmonization (ICH), applicable regulations and company SOPs.
• Act as global quality contact to all affiliates worldwide and maintain close relationships with local Quality counterparts, providing support, training and consultancy on local Quality Systems and GxP topics
• Conduct qualification or routine vendor audits of CROs and Vendors
• Assist in the management of the GCP audit program by maintaining audit logs, generating metric reporting, creating templates and others as needed.
• Management and closure of GCP CAPAs.
• Preparation and hosting activities during regulatory inspections and investigations conducted by various regulatory authorities, including the coordination of timely responses.
• Support Clinical QA projects.

Job Requirements :
• Ability to work in a fast-paced, collaborative, and dynamic environment.
• Strong experience in a Pharmaceutical/Biotechnology Clinical QA role with at least 4 years of clinical QA auditing experience.
• Strong CRO auditing experience
• Strong knowledge of global GCP regulations, guidance, and standards.
• Excellent collaboration skills.
• Ability to work independently.
• Excellent verbal and written communication skills.
• Demonstrated ability to effectively organize and execute tasks.
• Willing to travel up to 20%


For more information , please contact me on vamsi.gentela@secpharma.com or 00442072556638

Contact :

SEC PHARMA
vamsi.gentela@secpharma.com
 






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