Beschreibung
CS QA Lead Consultant
Whitehall resources are currently recruiting for a CS QA Lead Consultant for our client in Switzerland.
Objectives:
Providing independent oversight of computerized system validation and operational activities to confirm that computerized systems and regulated data are maintained in compliance with applicable Healthcare laws and regulations, policies and procedures. The CS QA Lead Consultant also drives and sustains improvements to computerized systems and the processes for implementing and supporting them.
Needed:
- Bachelor degree in Science, Business, Engineering, IT or related discipline or 5 years equivalent professional experience.
- Minimum 6 years experience with FDA Regulations, ICH, EMA and/or other international healthcare regulatory requirements including 21 CFR Part 11 and Annex 11.
- Minimum 4 years experience working with IT systems and teams
- Experience making quality assurance and compliance decisions in regards to software development, validation and support.
- Experience with all phases of Computerized System Validation and infrastructure qualification including use of GAMP 5 principles and risk based approach to computerized system validation
- Experience with all phases of System Development Lifecycles principles, processes and procedures.
- Experienced with Validation of SAP in global pharmaceutical environment
- Demonstrated multitasking project management and execution skills
- Ability to influence & negotiate with teams from all levels of the organization and external suppliers.
- Ability to read, analyze and interpret business plans, technical procedures, and government regulations
- Proven analytical and problem resolution skills; ability to identify root cause of problems
- Excellent verbal and written communication skills at the functional and technical level.
- Ability to understand complex business processes and recommend simplification where possible.
- Documented experience in working as part of a virtual team.
- Proficient in Microsoft Office products (Word, Excel, PowerPoint, Project and Visio).
If you are interested please get in touch with me via Email and Telephone: (see below).
Whitehall Resources are leading ERP Recruitment specialist in the provision of SAP, Oracle & IT recruitment in the UK and Internationally.