Description
Computerized Systems Quality Assurance Lead Consultant (m/f)
Reference: -en
Start: 06/18
Duration: 12 MM+
Main tasks:
- Provide independent oversight to assure that computerized systems are selected, implemented and maintained in compliance with procedures, regulations and guidelines
- Promote and champion support of compliance, quality and best practice oriented culture
- Authorize validation deliverables produced for computerized system projects
- Support development of Computerized Systems Quality Assurance related procedures and drive implementation of pragmatic, compliant, quality based solutions
- Participate in ongoing operational management activities including demand management, Change Advisory Board and Quality Metrics
- Conduct audits of computerized system vendors and 3rd party software providers including SaaS
- Identify and report quality or compliance concerns and take immediate corrective action
- Proactively identify risks/issues and share emerging industry standards/trends
- Plan, execute and report on internal audits of activities, records and processes related to regulated computerized systems and regulated data
- Collaborate with key business partners including IT, Vendors, Quality SMEs and Business System Owners to ensure activities are performed in line with regulatory requirements and industry standards
Main qualifications
- Profound knowledge of FDA Regulations, ICH, EMA and/or other international healthcare regulatory requirements including 21 CFR Part 11 and Annex 11
- Good work experience with IT systems and teams (virtual and onsite)
- Know-how making quality assurance and compliance decisions in regards to software development, validation and support
- Knowledge of all phases of Computerized System Validation and infrastructure qualification including use of GAMP 5 principles and risk based approach
- Familiar with all phases of System Development Lifecycle principles, processes and procedures
- Previous experience with Validation of SAP in global pharmaceutical environment
- Ability to influence & negotiate with teams from all levels of the organization and external suppliers
- Capability 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
- Proficient in Microsoft Office products (Word, Excel, PowerPoint, Project and Visio)
Main advantages:
- A highly motivated team and an open way of communication
- A very renowned company
- High degree of personal responsibility
- Interesting tasks in a multinational environment
About us:
IT professionals hold all the cards – if they are committed and have the right qualifications. Our customers in industry and the public sector are looking for motivated employees who like looking at the bigger picture and relish a challenge to fill IT positions on a project or permanent basis. We make sure that you, as an IT specialist, benefit from our many years of experience in IT recruitment and will find you the right role to suit your skills and interests – all completely free of charge to you. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.