At a Glance
- 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: Hybrid work model, collaborative culture, and opportunities for professional growth.
- Other info: Be part of a diverse team committed to innovation and quality.
- Why this job: Make a real impact on patient safety and regulatory compliance in a dynamic environment.
- Qualifications: Experience in computerised systems validation and strong knowledge of GxP compliance.
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.
- 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
Computer Systems Validation Specialist in Basildon, Essex employer: Pharmanovia
Pharmanovia is an exceptional employer, offering a dynamic and collaborative work environment in Basildon that prioritises innovation and accountability. As a Computer Systems Validation Specialist, you will play a crucial role in ensuring patient safety and regulatory compliance while benefiting from opportunities for professional growth within a rapidly expanding global pharmaceutical company. Join us to be part of a diverse team dedicated to revitalising trusted medicines and improving patient outcomes worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Computer Systems Validation Specialist in Basildon, Essex
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working at Pharmanovia. A friendly chat can open doors and give you insider info on what they’re really looking for.
✨Tip Number 2
Prepare for the interview by brushing up on GxP compliance and data integrity principles. We want you to show off your knowledge and how it applies to the role. Practice answering common questions and think of examples from your past experience.
✨Tip Number 3
Don’t forget to showcase your soft skills! Being able to communicate complex ideas clearly is key in this role. Think about how you can demonstrate your stakeholder management and collaboration skills during the interview.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re genuinely interested in joining our team at Pharmanovia. Let’s get you that interview!
We think you need these skills to ace Computer Systems Validation Specialist in Basildon, Essex
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 engaging and personal – we love to see your personality come through!
Showcase Your Achievements:When detailing your experience, focus on specific achievements rather than just listing duties. Did you lead a successful audit or implement a new validation process? We want to hear about it! Numbers and outcomes can really make your application stand out.
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. Plus, you’ll find all the details you need about the role and our company culture there!
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 responsibilities of the role.
✨Showcase Your Experience
Prepare specific examples from your past work where you've successfully managed computerised systems validation. Highlight your experience with EQMS and ERP systems, and be ready to explain how you handled compliance gaps or led audits.
✨Demonstrate Stakeholder Management Skills
Pharmanovia values strong collaboration, so think of instances where you've worked with cross-functional teams. Be prepared to discuss how you influenced stakeholders and communicated complex regulatory concepts in a clear way.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about their current challenges in compliance or how they measure success in computerised systems validation. This shows your genuine interest in the role and helps you assess if it's the right fit for you.
