Beschreibung
Our client, one of the biggest pharmaceutical companies based in Zurich area, is now looking for a Computerized Systems Quality Assurance Lead.
This is a contractual role: June 2018 - July 2019 .
Responsibilities:
- Provides independent oversight to assure that computerized systems are selected, implemented and maintained in compliance with applicable quality procedures
- Authorize validation deliverables produced for computerized system projects, including operational procedures, maintenance procedures and change requests
- Support the development of CS QA related procedures
- Conduct audits of computerized system vendors and 3rd party software providers
- Collaborate with key business partners including IT, Vendors, Quality SMEs and Business System
- Owners to ensure activities are performed in line with Takeda procedures, regulatory requirements and industry standards.
Must Have:
- 5+ years equivalent professional experience.
- 6+ years experience with FDA Regulations
- 4+ years experience working with IT systems and teams
- Experience with all phases of Computerized System Validation and infrastructure qualification including use of GAMP 5 principles
- Experience with all phases of System Development Lifecycles principles, processes
- Experienced with Validation of SAP in global pharmaceutical environment
- Proficient in Microsoft Office products (Word, Excel, PowerPoint, Project and Visio)