QA Senior Specialist

About the role

The QA Senior Specialist will support day‑to‑day Quality Assurance activities at a multi‑product cGxP contract manufacturing facility. You will work within a collaborative environment that values empathy, integrity and transparency while contributing to patient‑centric pharmaceutical solutions.

Key responsibilities

• Execute QA activities in line with approved SOPs and policies across Quality Systems, Validation, Technical Compliance or Operations.
• Review and approve SOPs, protocols, reports and records, ensuring data integrity and regulatory compliance.
• Troubleshoot process issues, identify operational factors, and choose optimal corrective actions.
• Lead small projects, manage deliverables and coordinate with internal and external stakeholders.
• Participate in deviation investigations, change controls, CAPA planning and execution.
• Provide QA oversight for laboratory services, engineering and validation activities.
• Develop skills to become a qualified trainer in your area of expertise.

Required profile

• In‑depth understanding of cGxP manufacturing processes and quality systems.
• Proven ability to review and approve quality documentation.
• Strong analytical and problem‑solving capabilities.
• Experience leading small projects and managing cross‑functional relationships.
• Commitment to uphold data integrity and continuous improvement.

Required skills

• SOP review and approval
• CAPA management
• Root cause analysis
• Deviation investigation
• Data integrity principles
• Change control processes