Senior Specialist QA

About the Company

Responsibilities

• ● rmation, and continuous improvement initiatives that enhance quality performance and support patient supply.
• ● 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.

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.
• ● 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
• ● Involvement in regulatory inspections, audits, and health authority interactions.
• ● Knowledge of quality management systems such as TrackWise or similar platforms.
• ● Familiarity with process improvement methodologies such as Lean, Six Sigma, or Operational Excellence frameworks.
• ● Join us and help ensure every product we deliver meets the highest standards of quality, safety, and patient impact.
• ● Date Posted 03-Sept-2026
• ● Closing Date 17-Sept-2026