QA Consultant
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. Apply today!
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
Veeva Vault Migration & Record Handling
- 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 We Do
Essential Pharma is an international specialty pharmaceutical company dedicated to maintaining access to clinically differentiated, niche medicines in small patient populations. Our high-impact portfolio includes over 300 medicines covering ten therapeutic areas, with a focus on the central nervous system (CNS), gastroenterology, ophthalmology, and rare diseases. Our products treat patients in more than 70 countries.
We are proactive in identifying low volume, difficult-to-manufacture therapeutic products, and late-stage clinical development assets that target rare diseases. Our recent acquisition of Renaissance Pharmaceuticals is a significant milestone for Essential Pharma, the groups second product for treatment of a rare disease, and the first development-stage asset in our portfolio.
In December 2024, Essential Pharma announced a €900 million recapitalisation with partners Gyrus Capital, welcoming AlpInvest and new strategic financing from Sixth Street.
Our business is comprised of around 70 people based out of our offices in Surrey UK, Malta, France, Spain and Switzerland.
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.
