Senior Quality Assurance Administrator

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