QA Specialist - 24 Month Secondment/FTC

About the Company

Responsibilities

• ● In this role, you will:
• ● Provide QA oversight and cGMP support for manufacturing activities across the Drug Substance and Drug Product facilities.
• ● Deliver on-floor Quality Assurance support during manufacturing operations, ensuring compliance with approved procedures, regulatory requirements and the Quality Management System (QMS).
• ● Act as the primary Quality contact during your assigned shift, providing real-time quality guidance, issue escalation and quality decision-making.
• ● Assess manufacturing events, deviations and exceptions, evaluating potential impacts to product quality, patient safety, compliance and supply.
• ● Participate in shift handovers, ensuring effective communication of quality risks, manufacturing issues and open actions.
• ● Review and approve quality and technical documentation, including SOPs, work instructions, technical reports, protocols and validation documentation.
• ● Support quality risk management activities and ensure risk assessments remain effective and compliant.
• ● Review and approve Master Batch Records in line with GMP principles and company procedures.
• ● Support inspection readiness activities, regulatory inspections and responses to inspection observations.
• ● Provide oversight of Quality Management System activities, including deviations, CAPAs, change controls and preventative maintenance programmes.
• ● Support vendor and supplier management activities and raw material qualification programmes.
• ● Develop, monitor and report quality metrics that drive operational excellence and compliance.
• ● Supporting Digital Innovation
• ● You will also play an active role in advancing digital and data-driven quality practices by:
• ● Supporting the digitalisation of Quality Assurance and manufacturing oversight processes.
• ● Using approved digital tools, reporting systems and analytics to strengthen quality oversight and continuous improvement.
• ● Supporting the implementation, validation and lifecycle management of digital technologies used within GMP environments.
• ● Contributing to the compliant adoption of AI-enabled and advanced analytics solutions in accordance with GxP, data integrity and governance requirements.
• ● Promoting effective use of approved digital and AI-enabled tools through testing, training, user engagement and change management activities.

Requirements

• ● Bachelor's degree in Science, Engineering or a related discipline, or equivalent combination of education and experience.
• ● Strong knowledge of cGMP requirements and pharmaceutical manufacturing regulations.
• ● Excellent attention to detail and a commitment to quality and compliance.
• ● Strong planning, organisational and prioritisation skills.
• ● Excellent communication and stakeholder management skills.
• ● Ability to work effectively within a shift-based environment supporting manufacturing operations.
• ● Knowledge of drug substance and/or drug product manufacturing processes.
• ● Strong technical capabilities in pharmaceutical manufacturing, compliance and quality systems.
• ● Why Alexion
• ● Every day, our work has the potential to impact patients living with rare diseases worldwide. You'll join a collaborative and innovative environment where quality, science and technology come together to deliver medicines that make a meaningful difference to people's lives.
• ● If you're passionate about quality, compliance and continuous improvement, and want to be part of a team committed to delivering excellence for patients, we'd love to hear from you.
• ● Apply today and help us deliver life-changing medicines to those who need them most.
• ● Date Posted 03-Sept-2026
• ● Closing Date 17-Sept-2026