Back to search.SEC Recruitment Ltd - Experienced GCP Manager, Switzerland
| Employment Type: | Permanent |
| Location: | Switzerland |
| Salary: | €50000 - €70000 per annum + standard benefits package |
| Languages: | English |
Responsibilities:
• Establishing strong relationship with local quality responsible within CPO
• Providing quality oversight quality (GCP) through up-to-date knowledge and understanding of the Clinical quality management System as well as international and local regulation and guidelines
• Provide expertise and guidelines to the quality responsible and clinical development CPO personnel in the implementation/execution of quality standards
• Drives the escalation process when local regulations affect global clinical trial execution
• Driving the process of preparation, facilitation and follow-up of local Health Authority Inspections
• Discussion with Quality Manager R&D on appropriate CAPAs and tracking of CAPAs
• Performance of root cause analyses
Requirements;
• Minimum 5 years experience of clinical development QA, industry, and Health Authority experience.
• Understanding of clinical trial methodology and medical terminology.
• Understanding of local requirements/practices for the conduct of clinical development activities.
• Expertise in the application of clinical development, and GCP requirements and processes.
• Ability to work effectively in a team environment.
• Effective training and facilitation skills.
• Experience in managing Health Authority inspections (FDA, EMEA, etc) is recommended.
• Highly effective communication, negotiation and leadership skills.
• Ability to maintain a high degree of independence with respect to decision making and problem solving.
• Ability to operate successfully in various cultural environments.
• Knowledgeable in application of computer system validation requirements.
This is an excellent opportunity with fantastic carrier prospect for the right person.
Please send your CV to Stephanie.Broize-Arrieu@secpharma.com or call Stephanie on 0207 255 664 for more details.
• Establishing strong relationship with local quality responsible within CPO
• Providing quality oversight quality (GCP) through up-to-date knowledge and understanding of the Clinical quality management System as well as international and local regulation and guidelines
• Provide expertise and guidelines to the quality responsible and clinical development CPO personnel in the implementation/execution of quality standards
• Drives the escalation process when local regulations affect global clinical trial execution
• Driving the process of preparation, facilitation and follow-up of local Health Authority Inspections
• Discussion with Quality Manager R&D on appropriate CAPAs and tracking of CAPAs
• Performance of root cause analyses
Requirements;
• Minimum 5 years experience of clinical development QA, industry, and Health Authority experience.
• Understanding of clinical trial methodology and medical terminology.
• Understanding of local requirements/practices for the conduct of clinical development activities.
• Expertise in the application of clinical development, and GCP requirements and processes.
• Ability to work effectively in a team environment.
• Effective training and facilitation skills.
• Experience in managing Health Authority inspections (FDA, EMEA, etc) is recommended.
• Highly effective communication, negotiation and leadership skills.
• Ability to maintain a high degree of independence with respect to decision making and problem solving.
• Ability to operate successfully in various cultural environments.
• Knowledgeable in application of computer system validation requirements.
This is an excellent opportunity with fantastic carrier prospect for the right person.
Please send your CV to Stephanie.Broize-Arrieu@secpharma.com or call Stephanie on 0207 255 664 for more details.
You cannot apply for this job as it is no longer active.
