Beschreibung
NextLink are currently working with a leading pharmaceutical organisation who are seeking an IT Quality Professional for their Basel offices. The candidate is being sought who has the experience, skills and background to work in a quality role supporting the Operations Quality and Compliance function. The individual should have a background in IT quality management related to the validation of computer systems and qualification of infrastructure.
Due to the ongoing COVID-19 crisis this role may start off as remote.
General information
Start date: 01.05.2020
Latest start date: 01.06.2020
End date: 31.12.2020
Extension: Extension possible, needs to be approved
Workload: 100%
Work location: Basel
Remote: max. 1 day per week (Friday)/prior approval needed
Tasks & Responsibilities
Provide independent quality support/quality oversight to teams on project and operational support activities (change management, periodic review, decommissioning).
Authoring and reviewing quality management documents (SOPs, Work Instructions, and Guides).
Providing support in risk management activities.
Provide input into process improvement.
Required Candidate Experience
5 years of experience in IT Quality Assurance, Quality Management
3 years of experience with computer system and device qualification.
Working knowledge of regulatory compliance requirements (ie ICH GCP, OECD Application of GLP Principles to Computerised Systems (Advisory Document no.17), EU GMP Annex 11, 21 CFR Part 11, ISO 9001, ISO 13485, ISO 14971, GAMP or other international standards)
Experience in the Software Development Lifecycle
Experience with testing tools (including: HP ALM, Jira and confluence)
Significant experience with documentation and technical writing skills, in a regulated compliance environment, is required.
Experience and understanding of risk management practices.
Experience with service management.
Flexible and able to work on several tasks in parallel.
Team player with very good communication skills.
Pragmatic and problem solving mindset.
Excellent written and spoken English language skills.
To apply for the role please send your CV to (see below)