Beschreibung
IT Quality Professional in Pharma - CSV
Background:
Roche Pharma Research and Early Development (pRED) translates world-class science into medical innovation through a diversity of technologies and talent located across seven research sites worldwide.
As part of pRED Business Sustainability, the Quality & Compliance Team acts as an entrusted partner that drives a behaviour-based Quality and Compliance culture. We enable pRED to translate internal and external requirements into sustainable, pragmatic and fit for purpose solutions, secure business continuity and pRED's "licence to operate". We offer GxP QM services to the pRED 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 pRED 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.
Role:
* Provide independent quality support/quality oversight to pREDi 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.
Requirements:
* 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.
Reference: 919220
Industry: Pharma
Location: Region Basel
Start: ASAP
Duration: 8 Months +
Work Load: 100%
About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.