Description
The Company:With more then 15 locations worldwide,my client is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible.For their headquarter in Geneva,Switzerland I am looking for a:
Job Title:
Senior Manager Quality Assurance
Requirements:
- 3-7 years of experience in QA specialy in Good Pharmacovigilance Practice (GVP) and/or drug safety experience is a must
- Experience in Quality Assurance
- Knowledge of ICH GCP Guidelines, EU and FDA Regulations as well as Guidelines on Directive /EU and Directive /EC
- Good written and verbal communication skills
- Relevant university degree in life science
- Basic computer skills
Specific Job Duties:
- Design and implement and manage an internal audit system of clinical and Pharmacovigilance processes
- Review existing SOPs/project specific plans and audit processes to ensure that staff are compliant with process
- Document audit findings/observations/recommendations in an audit report
- Track audit responses from teams
- Review audit findings/observations/recommendations and identify process improvement initiatives:
- Manage and/or conduct audits of internal processes/documentation to assess compliance with applicable regulations as well as SOPs and contractual requirements
- Manage and/or conduct process audits in all functional areas
- Maintain QA audit master audit schedule
- Maintain QA metrics regarding types of audits and reviews conducted
- Recommendations for process improvement
- Work with Director of Finance and General Manager or Director Regulatory Compliance and Process Implementation to forecast and track resourcing needs on a departmental level versus the annual corporate approved group budget
- Manage/coordinate the process of on-site Sponsor and Regulatory Audits - ensure regulatory inspection readiness
Miscellaneous:
- Assist in creation and maintenance of SOP`s
- Review/provide feedback regarding SOPs to ensure that applicable regulatory requirements are addressed
- Review new regulatory requirements and provide impact assessment regarding existing process and develop a remediation plan
- Perform investigator site audits upon request
- Conduct vendor assessments as necessary
- Assist the senior management and Project Management staff with any task impacting quality of services provided to clients
- Travel - approximately 25%
If you want to be a part of a very successful company who is expanding,rewarding their employees on an annual basis and most important a company who can secure you further professional development please dont hesitate to send me your CV in word format,contact me today at or
Looking froward hearing from you!