Description
QA Consultant wanted for our Zurich based client in the pharmaceutical sector.Your experience/skills:
- Bachelor degree in Science, Engineering, Business, IT or related field
- 6+ years' background with FDA Regulations, EMA, ICH or other healthcare regulatory requirements with 21 CFR Part 11 and Annex 11
- Strong background in working with IT systems and teams along with skillset in quality assurance and compliance decisions for software development, validation and support
- Practical knowledge and experience with all phases of Computerised System Validation and infrastructure qualification with GAMP 5 principles and risk based approach
- Familiarity with all phases of System Development Lifecycles as well as Validation of SAP in global pharmaceutical environment
- Languages: fluent English both written and spoken
Your tasks:
- Supervising and ensuring the selected and implemented computerized systems are in compliance with applicable quality procedures and regulations
- Authorising validation deliverables for computerised system projects, including operational procedures, change requests and maintenance procedures
- Supporting the development of CS QA related procedures along with participating in ongoing operational management activities
- Conducting audits of computerised system vendors and 3rd party software providers, including SaaS
- Identifying risks and issues in a proactively manner along with driving implementation of pragmatic, compliant and quality based solutions
- Collaborating with key business partners including IT, Vendors, Quality SMEs and Business System Owners and ensuring activities are performed in line with the standards of the company
Start: ASAP
Duration: 12MM+
Location: Zurich, Switzerland
Ref.Nr.: BH12902
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
Going the extra mile…
New to Switzerland? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more