Beschreibung
For our Pharma Client in the Basel area, we are looking for a
IT Quality Professional
Location: Basel
Contract type: temporary contract
Start/Ende:01.05.2020 - 31.12.2020
Background
Our client's R&D unit translates world-class science into medical innovation through a diversity of technologies and talent located across seven research sites worldwide.
As part of the R&D unit Business Sustainability, the Quality & Compliance Team acts as an entrusted partner that drives a behaviour-based Quality and Compliance culture. We enable to translate internal and external requirements into sustainable, pragmatic and fit for purpose solutions, secure business continuity and the licence to operate. We offer GxP QM services to the Informatics's quality management framework for the delivery and maintenance of qualified infrastructure and validated computerised systems. This includes a tailored process landscape with standard operations procedures, instructions, guiding and supporting documents. In addition, we offer training support for these processes and GxP aspects related to infrastructure qualification and computerised systems validation.
A candidate is being sought who has the experience, skills and background to work in a quality role supporting the R&D units 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.
Tasks & Responsibilities
Provide independent quality support/quality oversight to the 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.
Must Haves
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)