• Ensure all computer systems in the Quality Control Laboratory are validated as per 21CFR part 11. For all the rest of the Facility issue a VMP, assessing gaps and define actions to be fully compliant. For high risk systems assure closure of all gaps identified, in partnership with the Site Leadership Team
• Define and implement practical methods to ensure data integrity compliance across the site

• Responsible for assessing the current validation status of the Quality Control and Facilities related computer systems (e.g. Chromeleon, Malvern, FTIR, BMS, excel spreadsheets, etc…)
• Define and implement a Computer System Validation Master Plan
• Support the implementation of a Quality Management System (SOPs) for Computer System Validation and Data Integrity in partnership with the Quality Team
• Write related validation protocol and reports
• Implement a client data integrity strategy plan package
• Responsible for PQ of Computer Systems

• Education- Bachelor's degree in Engineering or related field

• Knowledge of industry validation standards
• 5-10 years of Computer Validation/ CSV experience within the Pharmaceutical/MHRA/FDA regulated industries
• Experience in Lab instruments and enterprise IT systems
• Demonstrated understanding and hands-on experience reviewing technical documents, including, validation documents, IQ/OQ/PQ validation protocols and reports

Knowledge/Skills Requirements:

• Strong communication, interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills Ability to organise and prioritise work.
• Ability to work under pressure to meet tight and changing deadlines
• Ability to be assertive to ensure appropriate GMP and business standards are achieved
• An accurate and systematic approach to work.
• Ability to work unsupervised, be self-motivated and take the initiative to introduce new ideas.
• Must be customer orientated
• Must have good written and verbal communication skills.
• A positive attitude to work.
• Good analytical and writing skills.

• Honesty and integrity.
• Detail-oriented with ability to accomplish objectives.
• Clear thinking/logical with strong personal organization skills.
• Able to work within a diverse, cross-functional team in a matrix organizational environment.
• Demonstrated competence in both written and verbal communication.

Business Environment:

• Performance driven.
• Collaborative and inclusive.

Attitude:

• Shows personal drive and self motivation
• Able to work with minimum supervision and to a high standard
• Comfortable working as part of a small team
• Work in a collaborative way.
• Results orientated.
• Positive, flexible and approachable.