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- Tasks: Lead CSV projects, author documentation, and manage testing of computerized systems.
- Company: Join Ideagen, a global leader ensuring safety in aviation, food, and healthcare.
- Benefits: Enjoy a UK home-based role with opportunities for training and professional growth.
- Why this job: Be part of a team that makes a real impact on safety and quality of life.
- Qualifications: 3-5 years in computer system validation; degree in science or IT preferred.
- Other info: Fluency in English and knowledge of regulatory requirements are essential.
The predicted salary is between 43200 - 72000 £ per year.
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Senior Advisory Consultant, Nottinghamshire
Client:
Ideagen
Location:
Nottinghamshire, United Kingdom
Job Category:
Consulting
EU work permit required:
Yes
Job Reference:
ae961a7e9e5b
Job Views:
6
Posted:
03.03.2025
Expiry Date:
17.04.2025
Job Description:
Role Purpose
Ideagen is the invisible force behind many things we rely on every day – from keeping airplanes soaring in the sky, to ensuring the food on our tables is safe, to helping doctors and nurses care for the sick.
So, when you think of Ideagen, think of it as the silent teammate that’s always working behind the scenes to help those people who make our lives safer and better.
Every day millions of people are kept safe using Ideagen software. We have offices all over the world including America, Australia, Malaysia, and India with people doing lots of different and exciting jobs.
The Senior Advisory Consultant will lead CSV projects on behalf of customers in alignment with GxP expectations and customer requirements. Their daily activities include authoring project-related CSV documentation, including Validation Plans, System Requirement Specifications, Design/Configuration Specifications, Risk Assessments, IQ/OQ/PQ Protocols and Reports, Traceability Matrices, Data Integrity Assessments, and Validation Summary Reports.
THIS ROLE IS UK HOMEBASED.
Responsibilities
- Manage and coordinate formal testing of computerised systems, including planning and writing of test cases, coordination of resources, execution of testing, completion, and approval of documentation.
- Follow Good Documentation Practices and adhere to Data Integrity requirements for completion of all documentation.
- Complete any allocated training (internal and customer requested) on time and in full.
- Investigate and troubleshoot any potential software issues/bugs.
- Communicate any software bugs or required updates as appropriate to software developers/vendors for appropriate resolution.
- Review computerised systems used in GxP processes to determine impact and develop a risk-based approach to meet global regulatory and customer requirements.
- Review CSV documentation to ensure data integrity expectations are maintained.
- Ensure project timelines are met to support customer commitments.
- Escalate any issues in a timely manner to ensure appropriate resolution.
- Perform and report 3rd Party audits on behalf of customers.
- Proactively highlight any areas for process improvement and actively contribute and participate in any internal continuous improvement initiative.
- Team Player – contribute knowledge to the IT Governance team, support more junior colleagues in their projects, help develop processes and good practices in project delivery.
Skills and Experience
- At least 3-5 years of experience with computer system validation.
- Degree in a science/health-related or IT-related subject or equivalent experience.
- Fluency in written and spoken English.
- A knowledge and understanding of a wide range of different types of systems used within the life sciences including MES, QMS, ERP, LIMS, SAS, SAP, etc.
- A knowledge and understanding of the requirements related to 21 CFR Part 11, EU Annex 11, Data Integrity, and GAMP.
- Experience in handling regulatory inspections and audits is an advantage.
- Computer literacy, including proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint).
- Ability to self-motivate.
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Senior Advisory Consultant, Nottinghamshire employer: TN United Kingdom
Contact Detail:
TN United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Advisory Consultant, Nottinghamshire
✨Tip Number 1
Familiarize yourself with the specific regulations and standards mentioned in the job description, such as 21 CFR Part 11 and EU Annex 11. This knowledge will not only help you during the interview but also demonstrate your commitment to compliance and quality in CSV projects.
✨Tip Number 2
Network with professionals in the life sciences and consulting sectors, especially those who have experience with computer system validation. Engaging with industry peers can provide valuable insights and potentially lead to referrals for the position.
✨Tip Number 3
Prepare to discuss specific examples from your past experience where you successfully managed CSV projects or handled regulatory inspections. Highlighting your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to work as a team player by preparing examples of how you've supported junior colleagues or contributed to process improvements in previous roles. This aligns well with the collaborative culture at Ideagen.
We think you need these skills to ace Senior Advisory Consultant, Nottinghamshire
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Senior Advisory Consultant position. Understand the key responsibilities and required skills, especially those related to computer system validation and GxP expectations.
Tailor Your CV: Customize your CV to highlight relevant experience in computer system validation and any specific projects that align with the responsibilities mentioned in the job description. Make sure to emphasize your fluency in English and any experience with regulatory inspections.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your understanding of Ideagen's mission. Mention how your background in life sciences or IT can contribute to their goals and how you can be a team player.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your application is clear, concise, and professional, reflecting your attention to detail.
How to prepare for a job interview at TN United Kingdom
✨Understand the Role and Responsibilities
Make sure you have a clear understanding of the Senior Advisory Consultant role. Familiarize yourself with CSV documentation, GxP expectations, and the specific responsibilities mentioned in the job description. This will help you answer questions confidently and demonstrate your knowledge.
✨Showcase Your Experience
Prepare to discuss your 3-5 years of experience with computer system validation. Be ready to provide examples of past projects where you managed testing, wrote documentation, or handled regulatory inspections. Highlight your familiarity with systems like MES, QMS, and SAP.
✨Demonstrate Problem-Solving Skills
Since troubleshooting software issues is part of the job, think of examples where you've successfully identified and resolved problems in previous roles. This will show your ability to handle challenges effectively and your proactive approach to process improvement.
✨Communicate Clearly and Effectively
As the role requires strong communication skills, practice articulating your thoughts clearly. Be prepared to discuss how you would communicate software bugs or updates to developers and how you ensure that documentation meets data integrity requirements.
