Quality Assurance Specialist

We are seeking an experienced Quality Assurance Specialist with a strong background in pharmaceutical manufacturing and regulatory compliance. The ideal candidate will have hands-on experience in Quality Assurance (QA) roles within the UK pharmaceutical industry and a deep understanding of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) regulations.

Key Responsibilities:

• Implement and maintain quality systems within pharmaceutical manufacturing sites in compliance with UK regulatory requirements.
• Conduct gap analyses on Quality Management Systems (QMS), prepare reports, and provide recommendations for continuous improvement.
• Support Quality Management in enhancing QMS processes, including Change Controls, CAPAs, Deviations, audits, risk assessments, and customer complaint investigations.
• Assist in the review and approval of batch production records to ensure compliance with Marketing Authorisation specifications.
• Develop and maintain Standard Operating Procedures (SOPs) and other quality documentation.
• Conduct root cause analyses and ensure investigations align with regulatory expectations.
• Support the development and implementation of electronic Quality Management Systems (eQMS), such as Q-Pulse (experience with such systems is beneficial).
• Assist in reviewing and updating key SOPs, ensuring alignment with regulatory requirements and internal quality standards.
• Undertake and develop risk assessments as required.
• Generate and analyze quality metrics, utilizing Microsoft Excel at an advanced level.
• Deliver training and coaching to staff on quality processes and regulatory requirements.

Key Skills & Experience:

• Proven experience in Quality Assurance roles within multiple UK pharmaceutical companies.
• Strong working knowledge of GxP regulations and pharmaceutical quality systems.
• Experience in continuous improvement initiatives related to Quality Systems.
• Ability to interpret regulatory guidelines and apply them effectively in a manufacturing environment.
• Strong organizational skills with the ability to prioritize workload and manage multiple tasks effectively.
• Self-motivated, detail-oriented, and capable of working independently.
• Excellent communication and collaboration skills, with experience in training and coaching.

This role offers an opportunity to contribute to a dynamic and regulated environment, ensuring compliance and quality excellence in pharmaceutical manufacturing. If you have the required experience and skills, we encourage you to apply.