Senior Specialist QA 24 Month SecondmentFTC

Location: Athlone Ireland

Shift: 7 / 7 Shift

Week 1: 7pm 7am (Mon Tues Sat Sun)

Week 2: 7pm 7am (Wed Thurs Fri)

Help bring life-changing medicines to patients

At Alexion quality is at the heart of everything we do. We are looking for a Senior Specialist Quality Assurance (Shift) to provide frontline Quality Assurance leadership and support across our manufacturing operations in Athlone.

This is a highly visible shift-based role where you will partner closely with Manufacturing Quality Control Engineering Site Services Planning and Qualified Persons to ensure compliant efficient and uninterrupted product supply. As a trusted quality expert you will provide real-time quality oversight support critical decision-making on the production floor and help ensure that every product released meets the highest standards of quality safety and compliance.

You will also play a key role in driving operational excellence digital transformation and continuous improvement initiatives that enhance quality performance and support patient supply.

What youll do

As a Senior Specialist Quality Assurance you will:

• Provide quality leadership and technical expertise across manufacturing operations during your assigned shift.
• Deliver direct on-floor QA oversight to ensure activities are performed in accordance with cGMP requirements approved procedures and the site Quality Management System.
• Act as the primary Quality Assurance contact during your shift supporting timely quality decisions and escalation of critical issues.
• Support manufacturing teams through real-time quality guidance issue resolution and risk-based decision-making.
• Review manufacturing activities documentation investigations and quality records to ensure compliance and quality standards are maintained.
• Partner with stakeholders across Manufacturing QC Engineering Planning Site Services and Quality functions to support reliable product supply.
• Lead or support deviation investigations root cause analysis activities and the development of effective corrective and preventive actions (CAPAs).
• Review and approve GMP documentation including SOPs validation documentation master batch records policies and quality reports.
• Provide quality oversight for validation technology transfer and new product introduction activities.
• Support Qualified Person (QP) batch release activities and regulatory compliance requirements.
• Contribute to inspection readiness activities and support internal customer and regulatory inspections.
• Coordinate quality priorities across manufacturing areas and ensure effective shift handovers.
• Drive continuous improvement initiatives that enhance compliance efficiency and right-first-time performance.
• Analyse quality data identify emerging trends and provide insights to support informed decision-making.
• Support the development and adoption of digital solutions automation opportunities and data-driven quality processes.
• Help evaluate and implement innovative technologies including artificial intelligence and advanced analytics solutions within a compliant GxP environment.
• Support training coaching and development activities across quality and manufacturing teams.
• Mentor and guide colleagues on quality systems compliance expectations and digital tools.
• Act as delegate for QA leadership colleagues when required.

Essential requirements

• Degree in Science Pharmacy Biotechnology Engineering or a related discipline or equivalent relevant experience.
• Significant experience working within pharmaceutical biopharmaceutical or other highly regulated manufacturing environments.
• Strong understanding of cGMP requirements and Quality Management Systems.
• Experience providing quality oversight within manufacturing packaging validation Quality Control or related operations.
• Experience supporting investigations deviation management CAPAs and risk assessments.
• Ability to make sound risk-based decisions in a fast-paced operational environment.
• Strong analytical and problem-solving skills with the ability to manage complex quality issues.
• Excellent communication collaboration and stakeholder management skills.
• Ability to interpret regulatory requirements and apply them pragmatically within operational settings.
• Strong organisational skills with the ability to manage multiple priorities and changing business needs.
• Willingness and ability to work a designated shift pattern while supporting manufacturing operations.

Preferred experience

• Experience within sterile aseptic biological or biopharmaceutical manufacturing environments.
• Involvement in regulatory inspections audits and health authority interactions.
• Experience supporting new product introductions technology transfers or validation programmes.
• Knowledge of quality management systems such as TrackWise or similar platforms.
• Experience using digital tools reporting systems data visualisation platforms or analytics solutions to improve quality outcomes.
• Experience supporting digital transformation initiatives within a regulated environment.
• Familiarity with process improvement methodologies such as Lean Six Sigma or Operational Excellence frameworks.
• Experience evaluating or implementing AI-enabled or advanced analytics solutions within a GxP environment.

Join us and help ensure every product we deliver meets the highest standards of quality safety and patient impact.

Date Posted

Closing Date