At a Glance
- Tasks: Ensure compliance of computerised systems and safeguard patient safety through GxP standards.
- Company: Fast-growing global pharmaceutical company focused on revitalising trusted medicines.
- Benefits: Hybrid work model, commitment to diversity, and opportunities for professional growth.
- Other info: Join a diverse team with a strong pipeline and expanding global presence.
- 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 understanding of GxP compliance.
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. 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.
- Ensure systems comply with regulatory expectations, including EU Annex 11, 21 CFR Part 11, GAMP and MHRA data integrity guidance.
- 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.
Demonstrated experience managing computerised systems validation in a pharmaceutical, biotech, or life sciences environment, with a strong focus on GxP compliance and validation processes.
- Good Manufacturing Practice (GMP) and GxP.
- 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. 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. 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.
Validation Engineer - Lab in Basildon employer: Pharmanovia
Pharmanovia is an exceptional employer that prioritises employee growth and development within a dynamic and inclusive work culture. Located in Basildon, our hybrid working model allows for flexibility while you contribute to the vital mission of improving patient outcomes through quality and compliance in the pharmaceutical industry. Join us to be part of a fast-growing global team where your expertise in computerised systems validation will directly impact patient safety and regulatory success.
StudySmarter Expert Advice🤫
We think this is how you could land Validation Engineer - Lab in Basildon
✨Tip Number 1
Network like a pro! Reach out to folks 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 be able to discuss how your experience aligns with their needs, so think of examples that showcase your skills in these areas.
✨Tip Number 3
Don’t just wait for the job to come to you! Apply through our website and make sure to follow up. A little persistence can show your enthusiasm and commitment to joining the team.
✨Tip Number 4
Showcase your problem-solving skills during interviews. Talk about how you've identified compliance gaps in the past and the steps you took to address them. This will demonstrate your proactive approach and fit for the role.
We think you need these skills to ace Validation Engineer - Lab in Basildon
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Validation Engineer role. Highlight your experience with GxP compliance and any relevant audits you've led or supported. 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 great fit for us. Keep it engaging and to the point.
Showcase Your Technical Skills:Don’t forget to mention your technical expertise, especially around regulatory expectations like EU Annex 11 and 21 CFR Part 11. We love seeing candidates who can translate complex concepts into practical solutions!
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 one step closer to joining our team at Pharmanovia!
How to prepare for a job interview at Pharmanovia
✨Know Your Regulations
Familiarise yourself with key regulations like EU Annex 11 and 21 CFR Part 11. Be ready to discuss how these impact computerised systems validation and patient safety, as this will show your understanding of the role's compliance requirements.
✨Showcase Your Experience
Prepare specific examples from your past roles where you managed GxP compliance or led audits. Highlight any successful remediation efforts or CAPA planning you've been involved in, as this demonstrates your hands-on experience in the field.
✨Communicate Clearly
Practice translating complex technical concepts into simple terms. During the interview, aim to explain how you would communicate compliance issues to non-technical stakeholders, showcasing your ability to bridge the gap between technical and regulatory aspects.
✨Ask Insightful Questions
Prepare thoughtful questions about Pharmanovia’s approach to data integrity and compliance. This not only shows your interest in the company but also gives you a chance to assess if their values align with yours, especially regarding patient safety and quality standards.
