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 salary, and opportunities for professional growth.
- Other info: Be part of a diverse team committed to innovation and quality in healthcare.
- 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 40000 - 50000 € 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.
Laboratory Validation Officer 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 Laboratory Validation Officer in Basildon
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect with professionals on LinkedIn. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by researching Pharmanovia and understanding their values and products. We recommend practising common interview questions and tailoring your answers to highlight your experience in GxP compliance and validation processes.
✨Tip Number 3
Showcase your skills! Bring along examples of your previous work related to computerised systems validation. We love seeing how you’ve tackled challenges and ensured compliance in past roles.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re excited to see how you can contribute to our mission of improving patient outcomes.
We think you need these skills to ace Laboratory Validation Officer in Basildon
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Laboratory Validation Officer 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 personal!
Showcase Your Technical Skills:Don’t forget to mention your technical know-how! Talk about your experience with 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 directly in our system, making it easier for us to review your application. Let’s get started!
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 computerised systems validation or led audits. Highlight your experience in identifying compliance gaps and how you addressed them, as this demonstrates your proactive approach.
✨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 CAPA planning, as effective communication is crucial in this role.
✨Ask Insightful Questions
Prepare thoughtful questions about Pharmanovia’s approach to GxP compliance and data integrity. This not only shows your interest in the company but also helps you gauge if their values align with yours, making for a more engaging conversation.
