Description
Validation Specialist - BT Quality vacancy for a globally operating pharmaceutical company based in Bern.Your experience/skills:
- 10+ years of experience working within pharmaceutical compliance/validation roles
- Strong knowledge of global health ministry (FDA, MHRA, etc) regulations governing the use of regulators computerized software technology
- Experience in Agile software development methodology and computerized system validation
- Experience with the following pharma/biotech business process areas preferred:Regulatory affairs, IDMP
- Experience in Project Management
- Experience in complex project organization, with multiple stakeholders and over multiple time zones and cultures.
Your tasks:
- Adhere to company cQMS and policies and procedures.
- Provide compliance advice and participate in project team activities with respect to the validation of
computerized business applications and other associated software/infrastructure solution. - Lead and/or participate in risk assessments with respect to regulatory issues and impact
- Prepare plans, protocols and reports in line with cGxP/ regulatory requirements and practices.
- Provide guidance to technology teams on scalable approaches to capture design/configuration
elements according to cQMS principles. - Organize testing (including defect management) and act as Test Manager.
Start: 01.02.2020
Duration: 24MM+
Location: Bern, Switzerland
Ref.Nr.: BH15226
Does this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more
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