CSV Analyst 12 Month FTC

Norgine Pharma SA; Hengoed; On-site; GBP 45,000 - 65,000; Full time

Job summary

Norgine in the United Kingdom is offering an exciting 12-month fixed-term contract for a CSV Analyst to join the IT Quality Management team. You will help ensure that validation activities, documentation and systems meet EU Annex 11 and 21 CFR Part 11 requirements, working with cross-functional colleagues and external consultants.

You will develop, review and implement CSV policies and plans, support risk-based validation, tests, audits, and maintain the Local Validation Master Plan, aiming to

Qualifications

• Bachelor’s degree preferred.
• Experience in validation and qualification of complex computer systems.
• Thorough knowledge of cGMP regulations related to CSV.
• Good written and oral communication skills.
• Competent user of Microsoft Office.

Responsibilities

• Assist the CSV/Lead Process Analyst in improving and delivering the global IT validation strategy.
• Support the validation of computerized systems and the risk-based validation approach.
• Develop, review and approve CSV policies, procedures, plans and protocols.
• Support project teams in defining validation levels based on risk assessments.
• Support the creation of validation packs to support the validated state.
• Maintain the Local Validation Master Plan and respond to audits and observations.
• Act as a Quality SME for CSV and Risk Management and coordinate with stakeholders.
• Provide guidance on GxP impact for new systems and ensure testing plans and scripts meet regulatory requirements.

Education

Bachelor’s degree

Experience in validation and qualification of complex computer systems

Thorough knowledge of cGMP regulations related to CSV

Good written and oral communication skills

Competent user of Microsoft Office

Job description

Description

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 and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a CSV Analyst 12 Months - FTC to join Norgine.

Core Responsibilities

This role is responsible for ensuring that Norgine IT Quality Management System, Validation documentation and all related processes, procedures and systems meet the requirements of all applicable regulations. This means not only working with other team members and consultants to identify any such weaknesses but also being instrumental in closing any such gaps identified. This may involve both directing others regarding what is needed and also making such changes themselves.

If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.

Requirements

• Assist the CSV/Lead Process Analyst in continued improvement and delivery of the Global IT validation strategy and approach taking into account the relevant GxP requirements (e.g. EU Annex 11, FDA 21 CFR Part 11, Part 820, etc.) and also other relevant regulatory requirements
• Support the continuous improvement of appropriate procedures to be used in validating computerized systems:
• Develop, review and approve CSV policies, procedures, plans and protocols, and champion their adoption.
• Support project teams in defining the appropriate level of validation required based on a risk assessment
• Support project teams in the creation of the agreed validation pack of documents to support the validated state
• Support the business functions in the periodic review of systems to assess the current validated state
• Acts as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Risk Management
• Review proposed changes to validated computerized systems and identify the validation requirements necessary to maintain the system’s validation status after execution of the change.
• Support project teams in the assessment of proposed new computerized systems or software for GxP impact and where GxP impact is identified provide guidance on the risk based validation approach for the system, working with key stakeholders to achieve business goals.
• Support formal testing of computerized systems ensuring that test plans, test scripts and test results comply with the regulatory requirements based on system risk.
• Ensure that the Local Validation Master Plan is maintained and is aligned to corporate policies as they relate to computer systems validation
• Assists in all forms of audit and responds to audit observations and corrective actions as they pertain to computer systems validation
• Interacts professionally with company management, internal departments and other areas of the business to effectively implement and maintain Quality Systems as they relate to CSV
• Identifies and implements improvement opportunities with the CSV/Lead process Analyst for established quality systems, processes, procedures, and training to support IT CSV activities
• Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer operations, and act as an information resource for the team and wider business.
• Such other activities as may be necessary from time to time

Education And Experience

• Bachelor’s degree preferred
• Experience in a validation and qualification of complex computer systems
• Thorough knowledge of cGMP regulations related to CSV
• Good written and oral communication skills
• Competent user of Microsoft Office

Technical Skills

• Familiarity with multiple system types such as ERP and BI, LIMS, HRIS etc.
• Good understanding of business requirements, high-level solutions and infrastructure components, combined with CSV system experience.
• Wide experience of the various regulatory requirements relating to Eudralex Annexe 11, FDA CFR21 Part 11, etc..
• Experience of the data integrity implications of the regulated environment

Team Skills

• Confident communicator, able to network effectively in a diverse business community.
• Proactive, professional approach, undertakes tasks and responds to business requests in a positive and constructive manner.
• Keeps industry and organization knowledge current in order to provide up to date solutions and be best placed to advise on future capabilities.

COMPETENCIES

SHAPING / LEADING / IMPACTING / CONTRIBUTING

Communication

• Reinforces Norgine's culture and values through appropriate communication styles and methods, taking into account language and cultural differences.
• Able to confidently and effectively communicate with smaller groups or individuals.
• Asks relevant questions to clarify understanding and determine appropriate action to be taken.
• Listens to information and interprets impact on immediate area.

Change

• Embraces change and sees it as an opportunity and deals with it constructively.
• Displays adaptability and flexibility in accepting change.
• Agrees and implements processes to enable change within area of responsibility.
• Seeks value-adding improvements to processes and services, even if it means challenging the status quo.

Leadership

• Understands Norgine's vision and values and considers actions accordingly.
• Leads by example in setting high personal performance standards.
• Has a positive influence within area of responsibility.
• Makes clear day to day decisions individually or collaboratively within area of responsibility, ensuring those affected understand decisions taken.

People & Relationship Management

• Develops positive working relationships with colleagues within area of responsibility and across associated functional areas.
• Readily shares knowledge, skills and experience to improve others' outputs.
• Recognises diversity and reinforces that discrimination, bullying and harassment is unacceptable.
• Deals with conflict situations and seeks to reduce negative impact.

Delivery (Results & Service)

• Shows a high level of awareness of the impact of actions on business results.
• Shows awareness of risks to business goals and understands contingency plans in place.
• Maintains high customer service standards and keeps customer informed.
• Recognises and understands the importance of "how" as well as "what" is achieved.

Personal Effectiveness

• Proactive with a focused and structured approach to work - although willing to change direction if required.
• Prioritises and manages time to achieve tasks.
• Displays resilience when under pressure.
• Possesses self awareness and is able to modify behaviour in different situations in order to be more effective.

Benefits

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.