At a Glance
- Tasks: Revise documents, support validation of complex systems, and collaborate for compliance.
- Company: Join a pioneering biopharma company focused on gene and cell therapy.
- Benefits: Gain experience in a high-profile project with potential for career growth.
- Why this job: Be part of an exciting team making a real impact in healthcare.
- Qualifications: Experience in validation roles within biopharma and understanding of GMP/MHRA.
- Other info: This is an 11-month contract position based in Oxford.
The predicted salary is between 36000 - 60000 £ per year.
Validation Specialist – UK, Oxford – 11 Month Contract
Are you aValidation Specialist professional with experience in Oxford? Are you looking to take the next step in your career and be part of an exciting new project? Then the position ofValidation Specialist is exactly what you’re looking for.
This is your chance to work for a company that is a pioneer in gene and cell therapy focusing on long-term curative treatments. With vast investment being made into the organisation and new build projects on the horizon this is the ideal time to join the team and establish yourself as a key team member.
Led by an experienced executive team, this is a fantastic opportunity to work for a high-profile Biopharma client.
Responsibilities:
- Revise and reformat existing URS documents using client’s internal templates.
- Author and review DQ and RTM documentation.
- Support validation of 9 high-complexity systems, including isolators and filling lines.
- Provide validation input for bioreactors and chromatography systems.
- Assist with validation of 40+ medium and low-complexity systems (e.g., benchtop equipment).
- Contribute to small-scale projects and ongoing validation activities.
- Collaborate with internal teams to ensure MHRA compliance following previous audit feedback.
Requirements:
- Extensive experience in validation documentation roles within a biopharma environment.
- Strong understanding of GMP and MHRA expectations.
- Proactive, personable, and capable of working independently.
- Not essential, but relevant qualifications are a plus.
If this role is of interest, apply now.
#LI-CY2
#J-18808-Ljbffr
Validation Specialist employer: Quanta Consultancy Services Ltd
Contact Detail:
Quanta Consultancy Services Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Specialist
✨Tip Number 1
Network with professionals in the biopharma industry, especially those who have experience in validation roles. Attend local industry events or join online forums to connect with potential colleagues and learn more about the company culture at StudySmarter.
✨Tip Number 2
Familiarise yourself with the specific validation processes and documentation standards used in the biopharma sector. This knowledge will not only help you during interviews but also demonstrate your commitment to understanding the role and its requirements.
✨Tip Number 3
Prepare to discuss your previous experiences with high-complexity systems and how you've contributed to compliance with GMP and MHRA standards. Be ready to provide examples that showcase your proactive approach and ability to work independently.
✨Tip Number 4
Research StudySmarter's recent projects and initiatives in gene and cell therapy. Being knowledgeable about our work will allow you to tailor your conversation during interviews and show your genuine interest in joining our team.
We think you need these skills to ace Validation Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in validation documentation roles within a biopharma environment. Emphasise your understanding of GMP and MHRA expectations, as these are crucial for the Validation Specialist position.
Craft a Compelling Cover Letter: Write a cover letter that showcases your proactive nature and ability to work independently. Mention specific examples from your past experiences that demonstrate your skills in revising URS documents and supporting validation activities.
Highlight Relevant Qualifications: If you have any relevant qualifications, be sure to mention them in your application. Even though they are not essential, they can set you apart from other candidates and show your commitment to the field.
Proofread Your Application: Before submitting your application, take the time to proofread all your documents. Check for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is vital for this role.
How to prepare for a job interview at Quanta Consultancy Services Ltd
✨Know Your Validation Documentation
Make sure you brush up on your knowledge of validation documentation, especially in a biopharma context. Be prepared to discuss your experience with URS documents, DQ, and RTM documentation, as these are key aspects of the role.
✨Understand GMP and MHRA Standards
Familiarise yourself with Good Manufacturing Practice (GMP) and the expectations set by the Medicines and Healthcare products Regulatory Agency (MHRA). Being able to demonstrate your understanding of these standards will show that you're serious about compliance.
✨Show Your Proactive Nature
During the interview, highlight instances where you've taken initiative in past roles. This could be through leading projects or improving processes. Companies value candidates who can work independently and take charge when needed.
✨Prepare for Team Collaboration Questions
Since the role involves collaborating with internal teams, be ready to discuss your teamwork experiences. Think of examples where you successfully worked with others to achieve a common goal, especially in high-pressure environments.