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QA Associate
£35,000 - £42,000
Full-time, Permanent
Are you passionate about ensuring top-tier quality in the fast-paced world of pharmaceuticals? We are looking for a dedicated QA Associate to join our clients dynamic team and play a crucial role in delivering life-changing therapies!
As a QA Associate, you will be a key player in safeguarding the quality and compliance of our clients cutting-edge products. You’ll provide critical support across multiple teams, ensuring the manufacturing operations and processes meet the highest standards. From document control to regulatory audits, your attention to detail and problem-solving skills will drive success across every phase of production.
Key Responsibilities:
* QA Oversight: Supervise daily manufacturing operations, providing on-the-ground QA support to ensure compliance with cGMP regulations and internal quality policies
* Batch Documentation: Review and approve batch records for accuracy, completeness, and compliance, ensuring the timely release of products
* Document Control: Generate, review, and approve essential GMP documentation, such as SOPs, change controls, CAPAs, deviations, and temperature excursions
* Audit Participation: Assist with internal audits, regulatory inspections, and customer audits, providing direct QA support during these critical reviews
* Continuous Improvement: Proactively initiate and support improvements in quality systems, working with cross-functional teams to implement changes
* Quality Training: Lead training sessions for staff on cGMP compliance, quality systems, and best practices, ensuring that the team remains up to date with industry standards
* Cross-Department Collaboration: Work closely with manufacturing, operations, and R&D teams to ensure alignment on quality goals and compliance with regulatory frameworks
* Root Cause Analysis: Conduct thorough investigations into incidents, deviations, and non-conformances, recommending corrective actions and preventive measures
* Quality Metrics: Contribute to the development and monitoring of quality performance indicators (KPIs) to drive continuous improvement across the business
* Regulatory Support: Support the timely submission of regulatory documents and ensure compliance with all site-specific authorizations
* Customer & Regulatory Audits: Provide key QA support during audits, ensuring readiness, compliance, and thorough follow-up on any audit findings
What You Bring:
* A Bachelor's degree in a scientific discipline (e.g., Chemistry, Life Sciences)
* A minimum of 1 year of experience in a GMP manufacturing environment, with a focus on Quality Assurance and Compliance
* In-depth knowledge of cGMP and experience in the pharmaceutical or biotech industry
* Strong problem-solving skills and the ability to conduct root cause analysis for quality issues
* IT literacy, with experience operating electronic Quality Management Systems (QMS)
Why Join Us?
This is your chance to be part of a forward-thinking company at the forefront of biopharmaceutical innovation. You’ll be working in a state-of-the-art facility, contributing to groundbreaking therapies that have the potential to transform lives. With a collaborative environment and a commitment to quality, you’ll have the opportunity to grow your career while making a real impact in the healthcare industry