Duration: 6 months
Our client is a consultancy in the food and pharmaceutical industry. They participate in very attractive projects for experienced engineers in the pharmaceutical industry. They offer challenging, varied projects with ample opportunities for personal contributions and development.
The focus of the CSV Specialist role is to identify or create industry best practices and implement these within the frame work of existing GMAP regulations. Responsibilities of the CSV Specialist function include both strategic implementation of CSV process improvements and tactical support of CSV operations to meet the changing needs of the business. The role reports into the Validation Manager at the site and requires a skill-set that incorporates the following.
- QA CSV Specialist represents the Quality Assurance department and act as a liaison between QA CSV and its internal and external customers;
- CSV Specialist continually monitors industry regulation and trends and applies this knowledge to optimize policies and procedures for completing a variety of tasks relating to the validation of computerized systems including process control systems, spreadsheets and bench top equipment;
- CSV Specialist must provide expert technical IT guidance to the Validation Manager for GMP decisions regarding the validation of computerized systems;
- this role is responsible for implementing continuous improvements to policies, procedures and VMPs to ensure the CSV department is operating as efficiently as possible by eliminating activities that
do not positively impact production capacity or compliance;
- experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement;
- as an experienced project manager the CSV Specialist must be capable of quickly developing a project scope, implementation plan and tracking mechanisms, while being forward looking to identify road blocks and solutions prior to issues impacting the project schedule;
- actively audit projects and systems to ensure that the appropriate validation activities are carried out in compliance with regulatory requirements & corporate standards;
- nn conjunction with engineering, controls, IT and other departments, evaluate new applications in order to identify validation requirements;
- act on behalf of, or be a conduit to, the Validation Manager on CSV issues to ensure that GMP issues are identified and addressed.
- Bachelor’s degree in Computer Science or Engineering;
- 6+ years of Computer Systems Validation or Controls/Automation Engineering experience;
- a broad general ICT / automation knowledge (eg data exchange, data security, infrastructure, PLC, SCADA, MES systems, etc.);
- familiar with work according to GAMP5;
- aware of the current insights regarding 21 CFR-Part11;
- communicate in English fluently.