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.
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