Computer Systems Validation Consultant
Computer Systems Validation Consultant - Ramsgate - 6 Month Contract
My client is a Global and one of the world's largest Pharmaceutical companies who are currently looking to recruit a Computer Systems Manager to join its well established team. Having been founded over 150 years ago and with close to 100,000 employees this is a chance to work for an esteemed and reputable company. The ideal candidate will be responsible for supporting the operations and deployment of Enterprise Business Technology (BT) supported Pharmaceutical Sciences Computer Systems. This role is responsible for ensuring that enterprise computer systems System LifeCycle Documents (SDLC) meet regulatory and the company's compliance requirements across Pharmaceutical Sciences sites.
The key experience and knowledge for the Computer Systems Validation Consultant include:
- Strong experience and knowledge of computer systems validation practices and regulatory requirements.
- Strong experience and knowledge of System Development Life Cycle methodology and requirements.
- Experience and knowledge of ERES and Data Integrity regulatory requirements.
- Experience and understanding to align business processes with technical solutions.
- Good understanding of IT systems (applications and infrastructure).
- Functional and technical knowledge and skills to do the job at a high level of accomplishment
- Proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities
- Proven ability to function autonomously in a matrix model and in a team environment
- Proven business management capability
- Proven ability to think creatively and to execute and manage strategic plans
- Logic and analytical skills - Uses rigorous logic and methods to solve difficult problems with effective solutions. Probes all sources for answers; can identify hidden problems. Is excellent at analysis. Goes beyond the obvious and seeks novel approaches to complex situations.
The key responsibilities for the Computer Systems Validation Consultant include:
- Review and approve System Development Life Cycle (SDLC) documentation, investigations and change controls related to enterprise Business Technology (BT) supported computer systems.
- Support the Pharmaceutical Sciences Quality Assurance (PSQA) collaboration tools and infopath forms.
- Responsible to liaison with their Global Supply (PGS) to ensure harmonization of validation practices.
- Review and approve PharmSci (PS) procedures related to enterprise BT supported computer systems.
- Act as the PSQA liaison/oversight/authority for our business lines, support groups and BT
- Support Data Integrity assessment activities through guidance and/or review.
- Lead or participate on special projects, teams and internal or external global initiatives.
- Support site-based and global activities including BOH inspections and corporate audits.
- Performs job responsibilities in compliance with cGMP and all other regulatory agency requirements.
This is a contract role for a Computer Systems Validation Consultant experience working for a top company on a global scale. To apply to Computer Systems Validation Consultant experience role please send a CV or call to discuss options.
We are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation, gender reassignment, marriage and civil partnerships, pregnancy or maternity or age