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For Companies At a Glance
- Tasks: Manage legacy QMS records and support documentation management in a dynamic team.
- Company: Join Essential Pharma, a leading international specialty pharmaceutical company.
- Benefits: Enjoy agile working, personal development plans, and a collaborative culture.
- Why this job: Make a real impact in quality assurance while working with innovative medicines.
- Qualifications: Degree in Life Sciences or related field; experience in GMP/GDP environments required.
- Other info: Embrace a culture of inclusivity and growth with regular access to leadership.
The predicted salary is between 48000 - 72000 £ per year.
Essential Pharma are looking for a Quality Specialist/QA Consultant to join our Quality Assurance team on an interim basis for 4 months. This role will have you managing the structured closure of legacy QMS records, migrating selected open or relevant records from the legacy QA system to Veeva Vault as well as documentation management and SOP writing.
What You Will Do
- Legacy Quality System Record Management
- Support the Quality System Manager in managing the structured closure of legacy QMS records.
- Review, assess, and close legacy Change Controls, Deviations, CAPAs, and Risk Assessments, ensuring alignment with applicable GMP/GDP requirements.
- Prioritize and execute record closures using a risk-based approach, escalating concerns or high-risk issues as required.
- Collaborate with the wider team members to standardize closure documentation for consistency and compliance.
- Migrate selected open or relevant records from the legacy QMS to Veeva Vault Quality QMS modules, ensuring traceability and accuracy.
- Liaise with Veeva Vault administrators or super users for system-related queries or support.
- Documentation Management & SOP Writing
- Draft and revise Standard Operating Procedures (SOPs) and Work Procedures (WIs) as assigned, aligned with EU GMP Chapter 4 and GDP guidelines.
- Ensure procedural documents are structured, validated, and submitted through correct approval workflows.
- Contribute to document harmonization initiatives during QMS transformation.
- Training & Site Quality Support
- Support GMP/GDP training initiatives, including drafting content, delivering sessions, and tracking training completion records.
- Assist in preparing training materials for new procedures or system changes (e.g., transition to Veeva Vault).
- Support internal audits or inspections as needed by ensuring documentation is complete and inspection ready.
What You Will Bring
- Degree in Pharmaceutical Sciences, Life Sciences, or related discipline (or equivalent experience).
- Additional certifications in Quality Assurance, GMP, or GDP are an asset.
- Veeva Vault system training or certification (desirable but not required).
- 3–5 years’ 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 ability to influence and guide without direct authority.
What To Expect
We wholeheartedly embrace agile working, recognizing that it enables individuals to bring their authentic selves to work. Our commitment to living by our values forms the bedrock of our inclusive culture, where everyone's voice is valued and respected. Treating each other as adults fosters a sense of autonomy and responsibility, while our inherent social nature is nurtured through engaging groups and events. We understand the significance of forging connections in the workplace, and our dedication to facilitating these bonds is underscored by regular access to our CEO. Grounded in the principles of dynamism, responsibility, trustworthiness, and collaboration, our values guide our interactions. Furthermore, our unwavering dedication to employee growth and learning is evident through our commitment to personalized development plans, as we believe in fostering an environment where all individuals can thrive. Right from the interview stage, we encourage candidates to ask us questions, as we understand that it's just as important for us to be the right fit for you as it is for you to be the right fit for us.
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Quality Assurance
Industries: Pharmaceutical Manufacturing
Quality Assurance Consultant in Egham employer: Essential Pharma
Contact Detail:
Essential Pharma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Consultant in Egham
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Essential Pharma. A friendly message on LinkedIn can go a long way in getting your foot in the door.
✨Tip Number 2
Prepare for the interview by researching the company and its values. Show us that you understand our mission and how your skills align with what we do. It’s all about making that connection!
✨Tip Number 3
Practice common interview questions, but don’t forget to prepare some of your own! We love when candidates ask insightful questions about the role or the team. It shows you’re genuinely interested.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows us you’re serious about joining our team at Essential Pharma.
We think you need these skills to ace Quality Assurance Consultant in Egham
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance Consultant role. Highlight your experience with QMS records, SOP writing, and any relevant certifications. We want to see how your skills align with 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 quality assurance and how your background makes you a great fit for our team. Keep it concise but engaging – we love a good story!
Showcase Your Experience: When detailing your experience, focus on specific achievements in managing QMS records and your familiarity with Veeva Vault. We appreciate concrete examples that demonstrate your expertise and problem-solving skills.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you're serious about joining our awesome team at Essential Pharma!
How to prepare for a job interview at Essential Pharma
✨Know Your QMS Inside Out
Before the interview, brush up on your knowledge of Quality Management Systems (QMS). Be ready to discuss your experience with legacy systems and how you've managed records like Deviations and CAPAs. This will show that you understand the role and can hit the ground running.
✨Showcase Your SOP Writing Skills
Prepare examples of Standard Operating Procedures (SOPs) you've written or revised in the past. Highlight how you ensured compliance with EU GMP guidelines. This will demonstrate your practical skills and attention to detail, which are crucial for this position.
✨Ask Insightful Questions
Interviews are a two-way street! Prepare thoughtful questions about the company's approach to quality assurance and their transition to Veeva Vault. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
✨Emphasise Team Collaboration
Be ready to discuss your experience working in cross-functional teams. Share specific examples of how you've influenced decisions without direct authority. This will highlight your ability to collaborate effectively, which is key in a role that involves liaising with various stakeholders.
