We are seeking a Quality Assurance (QA) Specialist to join our clients team. This is a senior-level role within the broader Quality function and plays a vital part in ensuring quality and compliance across site operations.
Reporting to a QA Senior Manager, the QA Specialist will serve as a Subject Matter Expert (SME) in assigned quality systems and be responsible for driving improvements, ensuring compliance with regulatory standards, and embedding best practices across the business.
This position is ideally suited for an experienced QA professional with strong knowledge of Deviation/CAPA, Change Control, QRM, and Documentation Management systems, as well as the ability to influence across cross-functional teams.
Key Responsibilities:
- Oversight and continuous improvement of key site quality systems, including Change Control, Deviation/CAPA, and Documentation Management.
- Provide expert input and guidance during Change Control and Deviation Review Boards.
- Management of Quality Risk Management (QRM) processes, including integration of QRM principles within quality frameworks.
- Maintain and enhance the Quality Management Review process and ensure alignment with corporate policies.
- Ownership of trending programs related to quality systems and the ability to interpret data to inform optimisation strategies.
- Monitor regulatory updates and ensure that the site quality systems remain compliant and inspection-ready.
- Drive sustained compliance initiatives, including self-inspections, internal audits, and continuous improvement activities.
- Develop and manage Quality Agreements relevant to the specialist area.
Basic Qualifications:
- Degree in Science, Engineering, or related discipline.
- 8+ years' experience in QA roles within the pharmaceutical or biotechnology industry.
Preferred Qualifications:
- Strong written and verbal communication skills.
- Experience with root cause analysis, investigations, and problem-solving.
- Excellent understanding of regulatory expectations and inspection readiness.
- Experience in aseptic operations, protein formulation, vial, and syringe filling is highly advantageous.
- Proven ability to manage cross-functional collaboration and influence stakeholders.