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 a 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 technologies.
- Qualifications: Experience in computerised systems validation and strong knowledge of GxP compliance.
The predicted salary is between 45000 - 55000 £ per year.
About the Company
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.
About the Role
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
Qualifications
Essential Experience & Knowledge
- 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
Required Skills
- 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
Why Join Pharmanovia
- 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
Equal Opportunity Statement
Pharmanovia is committed to diversity and inclusivity.
Computer Systems Validation Specialist in Basildon employer: Pharmanovia
Pharmanovia is an exceptional employer that offers a dynamic and collaborative work environment in Basildon, where innovation and accountability are at the forefront of our culture. As a Computer Systems Validation Specialist, you will play a vital role in ensuring patient safety and regulatory compliance while benefiting from opportunities for professional growth within a fast-growing 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
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those already 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 to see that you can translate complex concepts into practical solutions, so have some examples ready!
✨Tip Number 3
Show off your stakeholder management skills! Be ready to discuss how you've collaborated across teams in past roles. We love seeing candidates who can work independently but also influence others.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining our team at Pharmanovia.
We think you need these skills to ace Computer Systems Validation Specialist in Basildon
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? Share those wins with us – they 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 to the right people. Plus, it shows us you’re serious about joining our team at Pharmanovia!
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 regulations. Be ready to discuss how these principles apply to computerised systems validation, as Pharmanovia will be looking for someone who can translate complex regulatory concepts into practical guidance.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've managed computerised systems validation or led audits. Highlight your experience with EQMS and ERP systems, and be ready to discuss how you've handled compliance gaps and CAPA planning in previous positions.
✨Demonstrate Stakeholder Management Skills
Pharmanovia values strong collaboration, so think of instances where you've successfully worked with cross-functional teams. Be prepared to explain how you’ve influenced stakeholders at various levels and how you ensure everyone is aligned on compliance standards.
✨Ask Insightful Questions
At the end of the interview, don’t shy away from asking questions that show your interest in the role and the company. Inquire about their current challenges in computerised systems compliance or how they foster a culture of innovation and accountability within their teams.
