CSV Analyst - 12 Months FTC

Norgine; Hengoed; In loco; GBP 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

Norgine is hiring a Computer Systems Validation Analyst in the United Kingdom to ensure IT Quality Management and validation documentation meet GxP regulatory requirements. You will support the ongoing development of the Global IT validation strategy and approach.

This is a 12-month fixed-term contract. You will engage in CSV governance, risk-based validation, and cross-functional collaboration with Quality, IT and project teams to define validation requirements and maintain validated systems.

Competenze

• Demonstrable experience in Computer Systems Validation within a GxP-regulated environment.
• Good understanding of business requirements, high-level solutions and IT infrastructure alongside CSV experience.
• Strong understanding of regulatory requirements, including EudraLex Annex 11 and FDA 21 CFR Part 11.
• Good understanding of data integrity requirements within regulated environments.
• Experience developing, reviewing and maintaining validation documentation and records.
• Experience with risk-based validation, quality systems, change management and compliance risk management.
• Knowledge of quality assurance methodologies, requirements creation and verification, review and reporting, and data management techniques.
• Ability to work collaboratively across Quality, IT, business and project teams, providing guidance and SME input.
• Familiarity with ERP/BI, LIMS and HRIS would be beneficial.

Mansioni

• Execute and support risk-based CSV activities through the lifecycle of GxP systems.
• Develop, review and maintain validation documentation to keep systems validated.
• Support validation governance, planning, and Validation Master Plan maintenance.
• Coordinate validation testing, document outcomes and address issues and risks.
• Collaborate with Business, Quality, IT and project teams to define validation requirements.
• Support internal audits, regulatory inspections, periodic reviews and compliance assessments.
• Provide guidance on CSV, data integrity and regulatory requirements and improve CSV frameworks.

Conoscenze

CSV in GxP

Regulatory compliance

Data integrity

Documentation

Risk-based validation

Quality systems

Change management

Cross-functional collaboration

ERP/BI/LIMS/HRIS familiarity

Strumenti

ERP/BI

LIMS

HRIS

Descrizione del lavoro

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine, offering a fully-rounded experience where you can make a difference, continue developing and be part of a supportive community.

Norgine: Transforming Healthcare, Backed by Over a Century of Expertise.

We have an exciting opportunity for a Computer Systems Validation Analyst to join Norgine.

The Role:

The role is responsible for ensuring Norgine's IT Quality Management System, validation documentation, processes and systems meet applicable GxP and regulatory requirements. You will also support the continued development and improvement of the Global IT validation strategy and approach.

This is a 12-month fixed-term contract (FTC) role

Key Responsibilities

• Execute and support risk-based Computer Systems Validation (CSV) activities throughout the lifecycle of GxP systems, from implementation and enhancement through maintenance, review and retirement.


• Develop, review and maintain validation documentation to ensure systems remain in a validated state.


• Support validation governance, including validation planning, Validation Master Plan maintenance, change assessments and validation standards.


• Coordinate validation testing, document outcomes and support the assessment and resolution of identified issues and risks.


• Partner with Business, Quality, IT and project teams to ensure validation requirements are defined and maintained throughout system changes and projects.


• Support internal audits, regulatory inspections, periodic reviews and compliance assessments.


• Provide guidance on CSV, data integrity and applicable regulatory requirements, while contributing to continuous improvement of CSV frameworks, methodologies and processes.

Skills and Experience

• Demonstrable experience in Computer Systems Validation within a GxP-regulated environment.


• Good understanding of business requirements, high-level solutions and IT infrastructure alongside CSV experience.


• Strong understanding of relevant regulatory requirements, including EudraLex Annex 11 and FDA 21 CFR Part 11.


• Good understanding of data integrity requirements within regulated environments.


• Experience developing, reviewing and maintaining validation documentation and records.


• Experience with risk-based validation, quality systems, change management and compliance risk management.


• Knowledge of quality assurance methodologies, requirements creation and verification, review and reporting, and data management techniques.


• Ability to work collaboratively across Quality, IT, business and project teams, providing guidance and subject matter expertise.


• Familiarity with multiple system types such as ERP/BI, LIMS and HRIS would be beneficial.

We're looking for someone who demonstrates accountability, sound decision-making and integrity, with the confidence to address difficult issues, manage complexity and continuously improve how work is delivered.

These behaviours support Norgine's core values of Drive, Dare and Develop, including taking ownership, challenging constructively, seeking new ideas, collaborating effectively and valuing different perspectives.

This job advert summarises key responsibilities and is not exhaustive. Norgine may adjust responsibilities as needed.

Why Join Us?

At Norgine, you'll be part of an inclusive environment where diverse perspectives are valued. You'll have the opportunity to grow your career while making a meaningful impact on patients' lives.

Bring your curiosity, creativity and drive. However you work best, you'll find the support to succeed.

Ways of Thinking & Working to Support Your Growth

• Curious, reflective and open to different perspectives


• Collaborative across teams, functions and geographies


• Comfortable working independently and asking questions when needed

We are committed to building an inclusive workplace and welcome applications from all backgrounds. Our benefits may vary by location. Please liaise with the Norgine TA representative to obtain more information.

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