Quality Assurance Manager GCP

Zug  ‐ Onsite
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Description

Major Activities:
- Audit management:
o Provide guidance for the preparation, conduct and follow-up of GCP and Pharmacovigilance (PV) related audits.
- Inspection management:
o Provide support prior to, during and after health authority (HA) inspections within company's country organization and at investigational sites.
o Ensure that responses to local HA have been submitted, commitments have been met and relevant actions plans have been completed/closed.
- Deviations and Issues Management:
o Ensure that deviations and issues are properly managed in the internal tracking system including the respect of the escalation process.
o Support the investigation process (root cause analysis, action plan development) as appropriate.
- Management of vendors in the GCP / PV area as well as for Patient Oriented Programs (POPs):
o Perform (re-)qualification of vendors in the GCP / PV area as well as for external service providers involved in Patient Oriented Programs (POPs).
- Release activities:
o Perform the release of Investigational Medicinal Products for clinical trials, investigator-initiated trials and managed access programs.
o Ensure that all IMP release-related documents are filed in the related database.
o Keep oversight of release activities.
- SOP Management:
o Support the implementation of global SOPs to local Quality Management System.
o Review and update local SOPs, Working Practices and Forms.
Requirements:
Education: Degree in Life Sciences or related fields
Languages: German / English fluent in speaking and writing
Experience: Min. 3 years' experience in the pharmaceutical industry in a relevant field such as quality assurance, pharmacovigilance, clinical development or a directly related area
Additional Requirements: Strong project management skills, GCP und PV knowledge

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start date
02/2020
Duration
8 months
From
Michael Bailey Associates
Published at
13.11.2019
Project ID:
1847537
Contract type
Freelance
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