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- Tasks: Lead and execute validation activities for pharmaceutical clients, ensuring compliance and quality.
- Company: Join Rephine, a leader in quality assurance within the Life Sciences industry.
- Benefits: Competitive salary, remote work, flexible hours, and career development opportunities.
- Why this job: Make a real impact on critical projects while working remotely with a dynamic team.
- Qualifications: 5+ years in validation projects and strong understanding of GMP and GxP regulations.
- Other info: Collaborate with a multicultural team and drive digital transformation in the industry.
The predicted salary is between 36000 - 60000 £ per year.
At Rephine, we set the standard for quality assurance and GxP compliance in the Life Sciences industry. With offices in Barcelona, the UK, and China, we support Pharmaceutical, Biotech, and Medical Device supply chains globally.
We are looking for a Consultant (L2) – CSV to join our team remotely from the UK. This role is ideal for professionals with experience in validation and CSV projects who want to provide senior-level support to pharmaceutical clients, acting as a trusted consultant and technical reference.
Role PurposeProvide senior-level support to pharmaceutical clients in CSV, validation, and potentially other GMP-related projects, ensuring compliance and delivering high-quality consultancy services.
Key Responsibilities- Lead and execute CSV and validation activities (planning, risk assessments, IQ/OQ/PQ, reporting).
- Ensure compliance with GMP, GxP, and Data Integrity requirements.
- Act as the main client contact for validation topics.
- Review and approve validation documentation.
- Provide guidance and mentoring to junior consultants.
- Collaborate with client stakeholders in a consultancy environment.
- Manage project timelines and deliverables to meet client expectations.
- 5+ years in validation and CSV projects in the pharmaceutical or regulated environment.
- Strong understanding of GMP, GxP, and regulatory expectations (EU GMP Annex 11, FDA 21 CFR Part 11, GAMP5).
- Consulting or client-facing experience is a strong plus.
- University degree in Life Sciences, Engineering, or similar.
- Excellent communication and interpersonal skills.
- Proactive, structured, and solution-oriented mindset.
- Ability to work independently in remote project setups.
- Comfortable working in multidisciplinary, multicultural teams.
- Experience leading and participating in CSV projects across systems like ERPs, eDMS, eQMS, LIMS, SCADA, EBRs, and pharmacovigilance systems.
- Ability to assess system compliance with global regulatory standards.
- Fluent in English.
- Excited to work with clients on critical projects from a remote location in the UK.
- Comfortable managing technical, regulatory, and client-facing responsibilities.
- Eager to learn and grow in a role exposing you to diverse systems and industries.
- Competitive Compensation: Salary reflects your experience, plus additional benefits.
- Work-Life Balance: Remote work, flexible hours, shorter Fridays.
- Global Exposure: Multicultural team across multiple countries.
- Dynamic Environment: Young, enthusiastic team where your ideas are valued.
- Opportunities for Growth: Career development, leadership opportunities, and continuous learning.
- Drive Digital Transformation: Work on projects using the latest technologies to optimize quality processes.
For over 20 years, Rephine has helped leading Life Sciences companies improve manufacturing quality processes. Join us to grow your career and make an impact in a fast-evolving, global company.
Applications must be in English.
Locations
Computer System Validation Consultant in Hampshire, Portsmouth employer: Rephine
Contact Detail:
Rephine Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Computer System Validation Consultant in Hampshire, Portsmouth
✨Tip Number 1
Network like a pro! Reach out to your connections in the life sciences field and let them know you're on the lookout for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP, GxP, and CSV processes. Be ready to discuss your past projects and how you've tackled challenges in validation. We want to see your expertise shine!
✨Tip Number 3
Showcase your soft skills! Communication and teamwork are key in consultancy roles. Think of examples where you've successfully collaborated with clients or mentored junior colleagues to highlight your interpersonal abilities.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Computer System Validation Consultant in Hampshire, Portsmouth
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of a CSV Consultant. Highlight your experience in validation and compliance, and don’t forget to mention any specific systems you've worked with that are relevant to the job.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about the role and how your background makes you a perfect fit for Rephine. Keep it concise but impactful!
Showcase Your Soft Skills: Don’t just focus on technical skills; we want to see your communication and interpersonal skills too! Mention experiences where you’ve successfully collaborated with teams or mentored others.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands and shows us you’re serious about joining our team!
How to prepare for a job interview at Rephine
✨Know Your CSV Inside Out
Make sure you brush up on your knowledge of Computer System Validation (CSV) and related regulations like EU GMP Annex 11 and FDA 21 CFR Part 11. Be ready to discuss specific projects you've worked on, showcasing your experience in leading validation activities and ensuring compliance.
✨Showcase Your Consulting Skills
Since this role involves client-facing responsibilities, prepare examples that highlight your consulting experience. Think about times when you acted as a trusted advisor or provided guidance to clients, and be ready to explain how you managed project timelines and deliverables.
✨Communicate Clearly and Confidently
Excellent communication is key in this role. Practice articulating your thoughts clearly and confidently, especially when discussing complex topics like risk assessments and validation documentation. Remember, the interviewers will be looking for your ability to convey technical information effectively.
✨Demonstrate Your Proactive Mindset
This position requires a proactive and solution-oriented approach. Prepare to discuss situations where you identified potential issues before they became problems and how you took initiative to resolve them. This will show that you're not just reactive but also forward-thinking.