At a Glance
- Tasks: Support the Quality System Manager in closing legacy QMS records and migrating to Veeva Vault.
- Company: Join a leading speciality pharmaceutical company focused on innovative therapeutic products.
- Benefits: Enjoy a flexible work environment with opportunities for professional growth and development.
- Why this job: Be part of a dynamic team making a real impact in healthcare and patient outcomes.
- Qualifications: Degree in Pharmaceutical Sciences or related field; experience in GMP/GDP environments required.
- Other info: This is a 4-month contract role based in Surrey, England.
The predicted salary is between 36000 - 60000 £ per year.
Our client, a speciality pharmaceutical company based in the South of the UK, is looking for an Interim QA Consultant. Experts in their field, they focus on the central nervous systems, gastroenterology, ophthalmology, and rare diseases, identifying difficult-to-manufacture therapeutic products and working with trusted partners to get them to the market.
Responsibilities:
- Support the Quality System Manager in managing the structured closure of legacy QMS records.
- Prioritise and execute record closures using a risk-based approach, escalating concerns or high-risk issues as required.
- Migrate selected open or relevant records from the legacy QMS to Veeva Vault Quality QMS modules, ensuring traceability and accuracy.
- Ensure procedural documents are structured, validated, and submitted through correct approval workflows.
- Assist in preparing training materials for new procedures or system changes (e.g., transition to Veeva Vault).
- Timely closure of agreed legacy records and system.
- Working collaboratively in cross-functional teams.
Requirements:
- Degree in Pharmaceutical Sciences, Life Sciences, or related discipline (or equivalent experience).
- Extensive experience in a GMP/GDP-regulated pharmaceutical environment, ideally within a Quality Assurance or Compliance role.
- Proven experience in managing and closing Quality Management System (QMS) records such as Deviations, CAPAs, Change Controls, and Risk Assessments.
- Experience supporting migration from legacy systems to electronic QMS platforms, preferably Veeva Vault (Quality QMS).
- Demonstrated ability to write and revise Standard Operating Procedures (SOPs) in alignment with EU GMP (especially Chapter 4) and GDP requirements.
- Familiarity with risk-based decision making, including the application of ICH Q9 principles during record closure and quality actions.
- Experience collaborating across cross-functional teams, with the ability to influence and guide without direct authority.
If this role is of interest, please apply now!
Interim QA Consultant employer: Quanta Consultancy Services Ltd
Contact Detail:
Quanta Consultancy Services Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Interim QA Consultant
✨Tip Number 1
Familiarise yourself with Veeva Vault and its Quality QMS modules. Understanding how to navigate and utilise this platform will give you a significant advantage, especially since the role involves migrating records to this system.
✨Tip Number 2
Brush up on your knowledge of EU GMP regulations, particularly Chapter 4. Being well-versed in these guidelines will help you demonstrate your expertise during discussions and interviews.
✨Tip Number 3
Network with professionals in the pharmaceutical industry, especially those with experience in Quality Assurance roles. Engaging with others can provide insights into the company culture and expectations, which can be beneficial during your application process.
✨Tip Number 4
Prepare to discuss your experience with risk-based decision making and how you've applied ICH Q9 principles in past roles. Being able to articulate specific examples will showcase your suitability for the position.
We think you need these skills to ace Interim QA Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance and Compliance, particularly in a GMP/GDP-regulated environment. Emphasise your familiarity with QMS records and any specific experience with Veeva Vault.
Craft a Compelling Cover Letter: Write a cover letter that directly addresses the responsibilities and requirements listed in the job description. Use specific examples from your past experience to demonstrate how you meet their needs, especially regarding record closure and SOP writing.
Highlight Relevant Skills: In your application, clearly outline your skills related to risk-based decision making and collaboration across cross-functional teams. Mention any specific methodologies or principles you have applied, such as ICH Q9.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in a QA role.
How to prepare for a job interview at Quanta Consultancy Services Ltd
✨Know Your QMS Inside Out
Make sure you have a solid understanding of Quality Management Systems, especially in a GMP/GDP-regulated environment. Be prepared to discuss your experience with managing and closing QMS records like Deviations and CAPAs, as this will be crucial for the role.
✨Familiarise Yourself with Veeva Vault
Since the role involves migrating records to Veeva Vault, it’s essential to demonstrate your familiarity with this platform. If you have prior experience, be ready to share specific examples of how you’ve used it effectively in past roles.
✨Highlight Your Collaborative Skills
This position requires working collaboratively in cross-functional teams. Prepare examples that showcase your ability to influence and guide others without direct authority, as this will be key to succeeding in the role.
✨Prepare for Risk-Based Decision Making Questions
Expect questions around risk-based decision making and ICH Q9 principles. Brush up on these concepts and be ready to discuss how you've applied them in your previous roles, particularly during record closures and quality actions.