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: Enjoy a hybrid work model, competitive salary, 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 collaborative culture.
- Qualifications: 3-5 years in computerised systems validation with strong GxP compliance knowledge 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.
- Must have 3-5 years of experience working with Trackwise Digital.
- Experience with leading EQMS & ERP systems with a strong background in system administration and user experience.
- Computer system validation, along with 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.
Computer Systems Validation Specialist 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 fast-growing global pharmaceutical company. With a commitment to diversity and inclusivity, Pharmanovia fosters a supportive culture where your contributions are valued and recognised.
StudySmarter Expert Advice🤫
We think this is how you could land Computer Systems Validation Specialist
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Pharmanovia or similar companies. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GxP compliance and data integrity principles. Be ready to discuss how your experience aligns with the role and how you can contribute to patient safety.
✨Tip Number 3
Showcase your problem-solving skills! Think of examples where you've identified compliance gaps or led successful audits. This will demonstrate your expertise and ability to handle challenges in the role.
✨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
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, like Trackwise Digital. 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 in computerised systems validation makes you a perfect fit for Pharmanovia. Keep it engaging and personal – we love to see your personality!
Showcase Your Achievements:When detailing your experience, don’t just list your duties. Instead, showcase your achievements and how they contributed to compliance and quality in your previous roles. Numbers and specific examples can really make your application stand out to us!
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to submit all your documents in one go. Plus, it helps us keep track of your application better!
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 with Trackwise Digital
Since the role requires experience with Trackwise Digital, prepare specific examples of how you've used this system in past roles. Highlight any challenges you faced and how you overcame them, as this will demonstrate your problem-solving skills and familiarity with the software.
✨Prepare for Compliance Scenarios
Think about potential compliance gaps you might encounter in a pharmaceutical setting. Be ready to discuss how you would identify and address these issues, including your approach to CAPA planning and execution. This shows that you’re proactive and understand the importance of maintaining data integrity.
✨Emphasise Stakeholder Management Skills
Pharmanovia values strong stakeholder management and cross-functional collaboration. Prepare examples of how you've successfully worked with different teams or departments in the past. This will help illustrate your ability to influence and communicate effectively across various levels of an organisation.
