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- Tasks: Ensure compliance of computerised systems to safeguard patient safety and data integrity.
- Company: Join Pharmanovia, a fast-growing global pharmaceutical company with a diverse team.
- Benefits: Collaborative culture, career growth, and the chance to make a real impact.
- Other info: Be part of a diverse team committed to innovation and quality.
- Why this job: Play a vital role in patient safety and regulatory compliance in a dynamic environment.
- Qualifications: Experience in GxP compliance and strong stakeholder management skills required.
The predicted salary is between 45000 - 55000 £ per year.
Pharmanovia is a fast-growing global specialty 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.
- Strong knowledge of Good Manufacturing Practice (GMP) and GxP, EU Annex 11, 21 CFR Part 11, GAMP 5, Data integrity principles and MHRA expectations.
- Experience supporting or leading regulatory inspections and audits.
- 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.
Locations
Validation Specialist in Basildon, Essex employer: Pharmanovia
Contact Detail:
Pharmanovia Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Specialist in Basildon, Essex
✨Network Like a Pro
Get out there and connect with people in the industry! Attend events, join online forums, or even reach out to current employees at Pharmanovia on LinkedIn. Building relationships can open doors that a CV just can't.
✨Ace the Interview
Prepare for your interview by researching Pharmanovia's values and recent projects. Think about how your experience aligns with their mission to improve patient outcomes. Show them you’re not just another candidate, but someone who genuinely cares about their work!
✨Follow Up
After your interview, don’t forget to send a thank-you email! It’s a simple way to express your appreciation and reiterate your interest in the role. Plus, it keeps you fresh in their minds as they make their decision.
✨Apply Through Our Website
Make sure to apply directly through the Pharmanovia website. It shows you're serious about the opportunity and helps us keep track of your application. Plus, it’s the best way to ensure your CV lands in the right hands!
We think you need these skills to ace Validation Specialist in Basildon, Essex
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Validation Specialist role. Highlight your experience with GxP compliance and computerised systems validation, as these are key for us at Pharmanovia.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of how you've managed compliance in previous positions and how you can contribute to our mission of improving patient outcomes.
Showcase Your Attention to Detail: In the pharmaceutical industry, attention to detail is crucial. Make sure your application is free from typos and errors, and consider including a brief example of how your meticulous nature has benefited past projects.
Apply Through Our Website: We encourage you to apply directly through our website. This way, we can ensure your application gets the attention it deserves and you can easily keep track of your application status.
How to prepare for a job interview at Pharmanovia
✨Know Your GxP Inside Out
Make sure you brush up on your knowledge of Good Manufacturing Practice (GMP) and GxP compliance. Be ready to discuss how these principles apply to computerised systems validation, as this will show that you understand the core of what Pharmanovia is all about.
✨Showcase Your Audit Experience
Since the role involves leading and supporting audits, be prepared to share specific examples from your past experiences. Talk about how you handled regulatory inspections and what you learned from them. This will demonstrate your hands-on expertise and readiness for the challenges ahead.
✨Highlight Your Stakeholder Management Skills
Pharmanovia values strong collaboration, so think of instances where you've successfully managed stakeholders or worked cross-functionally. Share how you navigated complex situations and influenced decisions, as this will illustrate your ability to work effectively within a team.
✨Prepare for Technical Questions
Expect some technical questions related to computerised systems compliance and data integrity principles. Brush up on EU Annex 11 and 21 CFR Part 11, and be ready to explain how you would approach compliance gaps or risk assessments. This will show that you're not just knowledgeable but also practical in your approach.