Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Ensure compliance of computerised systems and safeguard patient safety in a dynamic pharmaceutical environment.
- Company: Join Pharmanovia, a fast-growing global speciality pharmaceutical company with a diverse team.
- Benefits: Collaborative culture, career growth opportunities, and the chance to make a real impact.
- Other info: Be part of a diverse team committed to quality and innovation.
- Why this job: Play a key role in patient safety and regulatory compliance while working with innovative medicines.
- Qualifications: Experience in computerised systems validation and strong knowledge of GxP compliance required.
The predicted salary is between 50000 - 65000 £ per year.
Pharmanovia is a fast-growing global speciality pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Since our founding in 2013, we have focused on revitalising niche, trusted medicines to improve patient outcomes worldwide. Our team of over 300 colleagues across 29 nationalities operates from offices in the UK, Denmark, the Netherlands, Switzerland, Italy, Spain, Germany, the UAE, India, Australia and Singapore. We are committed to delivering quality, innovation, and responsible lifecycle management of established medicines across our core therapeutic areas: Cardiovascular, Oncology, Endocrinology, and Neurology.
We are looking for an experienced Computerised Systems Compliance Manager to help safeguard patient safety through GxP compliance and data integrity.
Responsibilities- Provide overall compliance oversight for all GxP computerised systems across Pharmanovia.
- Ensure systems comply with regulatory expectations, including EU Annex 11, 21 CFR Part 11, GAMP and MHRA data integrity guidance.
- Develop, implement and maintain computerised systems validation and lifecycle management processes.
- Act as the organisation’s subject matter expert (SME) and primary point of contact for computerised systems compliance.
- Own and maintain the Site Validation Master File and validation documentation.
- Lead and support internal, client and regulatory audits relating to computerised systems.
- Review and approve system implementation plans, upgrades and change control activities.
- Identify compliance gaps and support remediation, CAPA planning, and execution.
- Conduct and communicate risk assessments associated with computerised systems.
- Establish and report KPIs related to computerised systems at Quality Review Meetings.
- Support supplier and system onboarding due diligence from a compliance perspective.
- Demonstrated experience managing computerised systems validation in a pharmaceutical, biotech, or life sciences environment, with a strong focus on GxP compliance and validation processes.
- Experience with leading EQMS & ERP systems with a strong background in system administration and user experience. Validating lifecycle management of these systems is essential.
- Previous QA experience in the management of (CAPA, Deviation, Change Controls, Complaints, PQRs, Management Reviews, recalls.
- Strong knowledge of:
- Good Manufacturing Practice (GMP) and GxP
- EU Annex 11
- 21 CFR Part 11
- GAMP 5
- Data integrity principles and MHRA expectations
- Ability to translate complex technical and regulatory concepts into clear, practical guidance.
- Strong stakeholder management and cross-functional collaboration skills.
- High attention to detail and strong documentation practices.
- Ability to work independently while influencing multiple levels of the organisation.
- Professional, reliable and committed to maintaining quality and compliance standards.
- Be part of a growing global pharmaceutical organisation with a strong pipeline and expanding footprint.
- Work in a collaborative, people-focused culture that encourages innovation and accountability.
- Play a key role in ensuring patient safety and regulatory compliance across a diverse portfolio of established medicines.
Pharmanovia is committed to diversity and inclusivity.
Computer Systems Validation Specialist in Chelmsford employer: Pharmanovia
Contact Detail:
Pharmanovia Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Computer Systems Validation Specialist in Chelmsford
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmaceutical and biotech sectors on LinkedIn. Join relevant groups, participate in discussions, and don’t hesitate to ask for informational interviews. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews by researching Pharmanovia inside out. Understand their products, values, and recent news. We want to see you shine when discussing how your experience aligns with their mission of improving patient outcomes.
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work related to GxP compliance and validation processes. We love seeing candidates who can demonstrate their skills through real-life scenarios, especially in a fast-paced environment like ours.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always on the lookout for passionate individuals who are ready to make a difference in the pharmaceutical industry.
We think you need these skills to ace Computer Systems Validation Specialist in Chelmsford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Computer Systems Validation Specialist role. Highlight your experience with GxP compliance and any relevant systems you've worked with. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about patient safety and how your background makes you a great fit for Pharmanovia. Keep it concise but impactful – we love a good story!
Showcase Your Compliance Knowledge: In your application, be sure to mention your understanding of regulatory expectations like EU Annex 11 and 21 CFR Part 11. We’re looking for someone who can navigate these waters confidently, so don’t hold back on your expertise!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just a few clicks and you’re done!
How to prepare for a job interview at Pharmanovia
✨Know Your GxP Inside Out
Make sure you brush up on Good Practice (GxP) guidelines, especially EU Annex 11 and 21 CFR Part 11. Be ready to discuss how these regulations impact computerised systems validation and share examples from your past experiences.
✨Showcase Your Compliance Experience
Prepare to talk about your previous roles in managing computerised systems validation. Highlight specific projects where you ensured compliance and data integrity, and be ready to discuss any challenges you faced and how you overcame them.
✨Demonstrate Stakeholder Management Skills
Pharmanovia values collaboration, so think of examples where you've successfully worked with cross-functional teams. Be prepared to explain how you communicate complex technical concepts to non-technical stakeholders.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions. Inquire about their current systems, upcoming projects, or how they handle compliance challenges. This shows your genuine interest in the role and helps you assess if it's the right fit for you.