The Senior QA Administrator is responsible for supporting and maintaining the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, company policies, and quality standards. The role involves managing quality documentation, coordinating quality processes, supporting audits and inspections, and driving continuous improvement initiatives across the organization.
Key Responsibilities
Quality Management System (QMS)
Maintain and administer the Quality Management System in accordance with company and regulatory requirements.
Control and manage quality documentation, including SOPs, policies, work instructions, specifications, and forms.
Ensure document review, approval, revision, and archiving processes are completed in a timely manner.
Monitor QMS effectiveness and identify opportunities for improvement.
Quality Records & Compliance
Maintain accurate and compliant quality records.
Ensure documentation complies with relevant standards such as ISO 9001, ISO 13485, GMP, GDP, or other applicable regulations.
Support compliance activities and ensure records are inspection-ready.
CAPA, Deviations & Non-Conformances
Coordinate and track Corrective and Preventive Actions (CAPAs).
Support investigations relating to deviations, complaints, non-conformances, and quality incidents.
Monitor action plans and ensure timely closure of quality issues.
Prepare quality trend reports and metrics for management review.
Audits & Inspections
Support internal, supplier, customer, and regulatory audits.
Assist in audit preparation, document retrieval, and follow-up activities.
Track audit findings and ensure corrective actions are completed within agreed timelines.
Training Administration
Maintain quality training records and training matrices.
Coordinate training assignments and ensure employees complete required quality training.
Monitor compliance with training requirements and generate periodic reports.
Supplier & Customer Quality Support
Assist with supplier qualification and approval activities.
Support customer quality questionnaires and quality-related requests.
Maintain approved supplier records and quality agreements where applicable.
Reporting & Continuous Improvement
Generate quality KPIs, reports, and dashboards.
Analyse quality data to identify trends and improvement opportunities.
Participate in continuous improvement projects and quality initiatives.
Support management review meetings with quality performance data.
Qualifications
Education
Bachelor’s degree in Quality Management, Science, Engineering, Business Administration, or a related discipline.
Relevant quality certifications (e.g., ASQ, CQI, ISO Lead Auditor) are advantageous.
Experience
Minimum 5 years’ experience in a Quality Assurance or Quality Systems role.
Experience within a regulated environment such as medical devices, pharmaceuticals, veterinary healthcare, manufacturing, or life sciences preferred.
Proven experience managing quality documentation and QMS processes.
Skills & Competencies
Strong knowledge of Quality Management Systems and regulatory requirements.
Excellent document control and administration skills.
Experience with electronic QMS systems.
Strong analytical and problem-solving abilities.
Excellent organizational and time management skills.
High attention to detail and accuracy.
Effective communication and stakeholder management skills.
Ability to manage multiple priorities and meet deadlines.
Proficient in Microsoft Office applications, particularly Excel, Word, and PowerPoint.
Key Performance Indicators (KPIs)
Timely completion of document reviews and approvals.
CAPA and deviation closure rates.
Audit readiness and audit findings closure performance.
Training compliance rates.
Quality system compliance metrics.
Accuracy and completeness of quality records.
Continuous improvement project participation and outcomes.
Working Relationships
Internal
Quality Assurance Team
Regulatory Affairs
Operations/Manufacturing
Supply Chain
Customer Service
Senior Management
External
Regulatory Authorities
Auditors
Suppliers
Customers
This role requires a proactive quality professional who can maintain compliance, improve quality systems, and provide administrative leadership within the Quality Assurance function.
Reports To
Quality Assurance Manager / Head of Quality
