At a Glance
- Tasks: Ensure compliance of computerised systems and safeguard patient safety through GxP standards.
- Company: Join Pharmanovia, a fast-growing global pharmaceutical company with a diverse portfolio.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Other info: Be part of a diverse team committed to quality and innovation.
- 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 50000 - 60000 € 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.
Quality and Validation Consultant (Contract) 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 offers flexibility while you contribute to meaningful projects that enhance patient safety and compliance in the pharmaceutical industry. Join us to be part of a fast-growing global company where your expertise will directly impact healthcare outcomes across diverse therapeutic areas.
StudySmarter Expert Advice🤫
We think this is how you could land Quality and Validation Consultant (Contract) in Basildon
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical and biotech sectors. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on GxP compliance and data integrity principles. Be ready to discuss how you’ve tackled compliance gaps in the past. Show them you’re not just familiar with the regulations but that you can apply them effectively!
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can go a long way. It shows your enthusiasm for the role and keeps you fresh in their minds as they make their decision.
✨Tip Number 4
Apply directly through our website! We love seeing candidates who are genuinely interested in joining us at Pharmanovia. Plus, it’s a great way to ensure your application gets into the right hands quickly.
We think you need these skills to ace Quality and Validation Consultant (Contract) in Basildon
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Quality and Validation Consultant. Highlight your experience with GxP compliance, data integrity, 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 perfect fit for us. Keep it engaging and relevant to the job description.
Showcase Your Achievements:Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've improved compliance or streamlined processes in previous roles. We love seeing quantifiable results that demonstrate your impact.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it’s super easy!
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 your achievements in identifying compliance gaps and how you supported remediation efforts, as this will demonstrate your hands-on experience.
✨Communicate Clearly
Practice translating complex technical concepts into simple terms. During the interview, aim to explain your thought process clearly, especially when discussing risk assessments or system implementation plans, as effective communication is key in this role.
✨Ask Insightful Questions
Prepare thoughtful questions about Pharmanovia’s approach to quality and compliance. Inquire about their current challenges in computerised systems validation or how they measure success in their quality review meetings, showing your genuine interest in the company and its goals.
