Associate QA Advisor (12-month fixed term contract)Pharmaron • Hoddesdon, England, United Kingdom
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Associate QA Advisor (12-month fixed term contract)
Pharmaron
- Hoddesdon, England, United Kingdom
- Hoddesdon, England, United Kingdom
À propos
Associate QA Advisor (12-month fixed term contract) – Location: Hoddesdon
Pharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 sites across the UK, US and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.
We’re proud of the impact we make; just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams work across small molecules, biologics, and advanced modalities, partnering with more than 3,000 global customers.
We are seeking an experienced Associate QA Advisor to join our Quality Assurance team in Hoddesdon. In this role, you will support the day-to-day operation of the Quality Assurance function by maintaining, optimizing, and governing the company’s electronic Quality Management System (eQMS). This role ensures that TrackWise is configured, validated, and used in alignment with GxP requirements, internal procedures, and global regulatory expectations. The administrator acts as a system expert, business partner, and QA guardian for all TrackWise-related processes.
This is a fantastic opportunity for a QA professional who combines technical expertise with leadership, attention to detail, and a commitment to continuous improvement. If you are passionate about quality and ready to contribute to high-impact pharmaceutical manufacturing, we would love to hear from you.
Please note:
Unfortunately, we are unable to offer visa sponsorship for this position, now or in the future. Candidates must have the right to work in the UK at the time of application.
At Pharmaron we offer:
Vibrant and dynamic employment
– we are a highly specialised, fast-growing company operating in a critical sector with a strong future.
A supportive and collaborative team culture
– enjoy your work in an environment where colleagues support one another and strive for excellence.
State-of-the-art facilities
– our Hoddesdon site includes world-class R&D and GMP manufacturing capabilities.
Key Roles and Responsibilities
System Administration
Manage day-to-day TrackWise operations, including user account management, role assignments, and system configuration.
Maintain system master data, workflows, forms, and controlled documents.
Oversee system performance, troubleshoot issues, and coordinate the vendor as needed.
Quality & Compliance Oversight
Ensure TrackWise is maintained in a validated state in accordance with GxP, 21 CFR Part 11, EU Annex 11, and internal quality standards.
Support audit and inspection readiness by providing system documentation, access logs, and data extracts.
Review and approve system change controls, deviations, and validation deliverables.
User Support & Training
Provide support to end users, resolving system issues and guiding proper use of TrackWise.
Data Integrity & Reporting
Generate dashboards, KPIs, and management reports to support QA oversight.
Support trending, investigations, and quality reviews with accurate system data.
Additional Expectations
Foster a culture of transparency, trust, and continuous improvement.
Act in full alignment with GMP, internal policies, SOPs, and patient-safety principles.
Maintain up-to-date knowledge of relevant UK, EU and US regulatory guidance.
Promote a “Quality is everyone’s responsibility” mindset and lead by example.
Requirements
BSc degree in Chemistry or a related scientific field (essential).
Minimum 8 years of QA experience in an API or Drug Product GMP pharmaceutical environment.
Experience with TrackWise.
Why Should You Apply?
This is an opportunity for you as a QA professional to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
Build and shape your career in an environment that sets and commits to the highest standards.
Be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.
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Compétences linguistiques
- English
Avis aux utilisateurs
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