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.
- Other info: Embrace a culture of inclusivity and growth with regular access to leadership.
- 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.
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
Essential Pharma is an excellent employer, offering a dynamic work environment that prioritises patient-centric growth and collaboration within the Medical Affairs Team. Employees benefit from extensive travel opportunities, a supportive culture that fosters professional development, and the chance to make a meaningful impact in the field of respiratory health across the UK and Ireland.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Consultant in Egham
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We think you need these skills to ace Quality Assurance Consultant in Egham
Some tips for your application 🫡
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How to prepare for a job interview at Essential Pharma
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Essential Pharma that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
