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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. If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.
Job Responsibility:
Ensure that Norgine IT Quality Management System, Validation documentation and all related processes, procedures and systems meet the requirements of all applicable regulations
Work with other team members and consultants to identify any such weaknesses
Be instrumental in closing any such gaps identified
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 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
Act 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
Assist in all forms of audit and respond to audit observations and corrective actions as they pertain to computer systems validation
Interact professionally with company management, internal departments and other areas of the business to effectively implement and maintain Quality Systems as they relate to CSV
Identify and implement 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
Requirements:
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
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
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
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
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
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
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
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
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