IT Computer Validation Manager
- Job Type:
- Date Posted:
- Excellent + bens
- Now Expired
THIS JOB HAS NOW EXPIRED.
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities.
This is your chance to become part of a team that helps to bring the miracles of medicine to market sooner.
About the Job
Considered to be a senior leader position within Covance’s computer Systems validation (CSV) team, this key appointment will lead, advise and implement computer validation for all major IT projects across the EMEA for pre-clinical, toxicology programmes and analytical services. In this position you will significantly impact Covance’s compliance of systems, working alongside a dynamic team and driving business improvements. Responsibilities for this position will include:
- Lead, mentor and manage the CSV (computer systems validation) team
- Working with project teams to ensure that test requirements are identified and testing phases are designed to meet system needs
- Prepare test strategy documents and sizing estimates for various projects
- Ensuring test plans are designed and documented and that test cases for applications are specified
- Managing the performance of application, functional, usability, performance load-stress, and user acceptance tests
- Ensuring software faults are identified and documented and ensuring interaction with development staff so testing issues are isolated and resolved
- Ensuring product functionality is validated and documented across releases
- Driving the implementation of a common SDLC (software development life cycle)
- Enforcing current Covance standard testing methodologies, procedures and practices
- Periodically conducting training for other team members
- Establishing and maintaining working relationships with operational groups and other sections of IT
- Performing documentation reviews
- The individual has a responsibility to conduct all work in compliance with applicable GLP, GCP and cGMP regulatory requirements.
- A Bachelors Degree (or equivalent experience) is required, preferably in a science related subject (e.g. Chemistry, Biology, Biotechnology etc.)
- Extensive knowledge of Computer Systems Validation (CSV) within regulated industries
- Significant managerial and technical experience working across some of the following IT disciplines: software development, IT compliance, IT quality, business analytics, and/or business engagement
- Knowledge and understanding of appropriate and relevant regulations, for example OECD Series on Principals of Good Laboratory Practice and Compliance Monitoring Number 10
- Knowledge and understanding of the appropriate EMEA or FDA Regulations
- Extensive knowledge and experience of system life cycle methodologies and how they relate to other industry standard methodologies and regulations.
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
There is no better time to join us!
Covance is committed to diversity in the workplace and is an equal opportunity employer. Your confidentiality and privacy are important to us.
Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medic...View This Employers Profile >>
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