Senior Quality Assurance Officer

The Senior Quality Assurance (QA) Officer plays a key role in maintaining compliance, supporting quality processes, and engaging with internal and external stakeholders. Responsibilities include:

Core Quality Responsibilities

• Act as a Quality Subject Matter Expert, partnering with internal teams and external customers on quality-related topics.
• Review and prepare batch records for QP batch disposition within defined timelines.
• Assess and approve major/minor deviations, investigations, CAPAs, and change requests within due dates.
• Ensure batch records are closed and archived once all related activities are completed.
• Attend project meetings, providing quality insights and identifying key requirements.
• Complete QA deliverables associated with change controls, deviations, and CAPAs.

Compliance & Documentation Management

• Review and approve SOPs, forms, master batch records, checklists, protocols, reports, and test methods within the Document Management System.
• Ensure all document changes are justified, follow proper procedures, and contain appropriate references.
• Manage and track Key Performance Indicator (KPI) quality metrics, representing the department in site meetings, including batch release, deviation/change review boards, IPT, JPT, and quality council.

QA On-the-Floor & Continuous Improvement

• Conduct QA On-the-Floor activities, witnessing and supporting manufacturing, production, warehouse, and quality control processes.
• Provide training and mentorship to junior QA professionals and relevant departments, ensuring best practices are upheld.
• Drive continuous improvement by identifying efficiency opportunities and ensuring compliance within operations.

Qualifications

• Degree: BA/MA in Science, Biotechnology, or a related discipline.
• Language: Native English proficiency.
• Experience: 5-10 years of advanced expertise in Quality Assurance & GMP compliance.