Global Quality Computerised System Validation CSV Lead

An exciting opportunity to join a newly formed global Quality team and develop this role from 'ground-up', this is a position for a Computerised System Validation (CSV) specialist. The principal responsibility is to ensure that new software and systems are suitably validated to improve efficiency, regulatory compliance and ultimately patent safety.

Working collaboratively with the internal Quality and Technology teams, the jobholder will be responsible for developing and delivering a global CSV plan to support the business strategy and requirements.

Acting as Global CSV advocate and subject matter expert, developing Uniphar group-wide policies, documentation, and procedures to streamline and rationalise group CSV practices.

This role will involve significant international interaction and some international travel.

MAIN DUTIES & RESPONSIBILITIES

• To ensure that new and developing software and systems are appropriately validated to improve efficiency, regulatory compliance and ultimately patent safety.
• To develop and deliver a global CSV plan in collaboration with Business, Technology and Quality teams.
• Advocating for, and act as Global CSV subject matter expert, working with existing group companies and new acquisitions to integrate their existing CSV practices and platforms into the group solution.

• Engaging, directing, and supporting colleagues to participate in the CSV process.

• Ensure CSV compliance with regulatory, customer and other relevant standards.
• Developing and rolling out Uniphar group-wide policies, documentation, and procedures to streamline and rationalise group CSV practices. Ensuring these are aligned and integrated with business strategy and priorities.

• Develop group wide CSV reporting and KPIs.

• Communicating the importance of the CSV requirements and engaging, directing and supporting people to participate in the validation of computerised systems.
• The jobholder may also from time to time participate in vendor and customer audits.
• This role will involve significant international interaction and some international travel.

QUALIFICATION, EXPERIENCE & SKILLS REQUIRED

• CSV subject matter expert, with at least 2 years experience in this field
• Experience in Pharma/medical device Computerised System Validation using GAMP5 or similar methodology.
• Hands on experience in developing and producing CSV reports in a GxP environment.
• High level of IT fluency, able to understand complex systems, architecture and connectivity.
• Ability to communicate internally at all levels, able to translate between Business, Quality and Technical teams to ensure robust understanding and compliance.
• Customer focus, able to ensure customer requirements are understood and delivered.

QUALIFICATION, EXPERIENCE & SKILLS DESIRABLE

• Experience with US FDA CFR21 compliance
• EU GMP Annex 11 requirements for computerised systems
• Completion of a recognised CSV
• Experience in multiple regulatory and operational jurisdictions

COMPETENCIES

• Concern for order and quality.
• Technical ability- IT systems, MS applications.
• Communication skills, including oral communication, report writing, and presentation skills.
• Problem-solving skills, including analytical and critical thinking, and data analysis.
• Knowledge of GDP, GMP, ISO, QMS, regulatory changes, industry standards, and pharmaceutical sector.
• Professionalism and ethics, including personal behaviour, confidentiality, and objectivity.
• Impact and Influence at all levels