Faamuina Tuiatua
42 Vailima Road, Apia, Samoa
+685 7234 8891 | faamuina.tuiatua@email.com | linkedin.com/in/faamuinaturiatua

PROFESSIONAL SUMMARY

Results-driven Quality Assurance professional with over 8 years of experience in pharmaceutical and medical device manufacturing environments. Proven expertise in regulatory compliance, process validation, and quality management systems. Skilled in leading cross-functional teams to implement corrective and preventive actions, conduct risk assessments, and ensure GMP adherence. Strong track record of optimizing quality processes and driving continuous improvement initiatives.

PROFESSIONAL EXPERIENCE

Assistant Manager, Quality Assurance
Pharmatech Solutions Ltd., Auckland, New Zealand
March 2022 – Present

• Lead quality assurance operations for pharmaceutical manufacturing facility, overseeing team of 6 QA specialists and ensuring compliance with FDA, EMA, and ICH guidelines
• Manage process validation activities including IQ/OQ/PQ protocols for aseptic processing equipment, resulting in 100% regulatory inspection readiness
• Conduct comprehensive root cause analysis and implement CAPA systems that reduced quality deviations by 35% over 18 months
• Oversee equipment qualification programs and calibration schedules for critical manufacturing instrumentation, maintaining 99.8% compliance rate
• Collaborate with manufacturing, engineering, and regulatory affairs teams to resolve quality issues and optimize production processes
• Develop and deliver GMP training programs to 150+ employees, achieving 98% training completion rate

Quality Assurance Specialist
Oceania Biomedical Industries, Wellington, New Zealand
June 2019 – February 2022

• Performed quality control testing and review of batch records for sterile injectable products in compliance with cGMP requirements
• Conducted Failure Mode and Effects Analysis (FMEA) for new product launches and process changes, identifying critical control points
• Managed change control documentation and assessed impact of manufacturing changes on product quality
• Participated in regulatory inspections and internal audits, contributing to successful FDA audit with zero 483 observations
• Created and maintained quality documentation including SOPs, protocols, and technical reports using electronic quality management systems

Quality Control Analyst
Pacific Analytical Services, Sydney, Australia
August 2017 – May 2019

• Executed analytical testing using chromatography techniques (HPLC, GC) to verify raw materials, in-process samples, and finished products
• Maintained laboratory equipment and performed routine calibration and preventive maintenance activities
• Investigated out-of-specification results and documented findings in compliance with regulatory requirements
• Supported validation activities for analytical methods and laboratory equipment qualification
• Contributed to continuous improvement initiatives that reduced testing turnaround time by 20%

EDUCATION

Bachelor of Science in Chemistry
University of the South Pacific, Suva, Fiji
Graduated: May 2017

CERTIFICATIONS

• Certified Quality Auditor (CQA) – American Society for Quality
• Aseptic Processing Training Certification
• Root Cause Analysis and CAPA Management

TECHNICAL SKILLS

Quality Systems: GMP, Quality Assurance, Quality Control, Process Validation, Equipment Qualification, Regulatory Compliance, Risk Management, Change Management, CAPA, Accreditation

Technical Expertise: Aseptic Processing, Chromatography, Calibration, Testing, Instrumentation, HVAC Systems, Piping and Instrumentation Drawing (P&ID)

Tools & Software: Visio, Records Management Systems, Documentation Management

Leadership & Management: Team Leadership, Project Management, Stakeholder Management, Employee Training, Training & Development

Analytical Skills: Root Cause Analysis, Failure Mode and Effects Analysis (FMEA), Risk Management, Optimization

PROFESSIONAL AFFILIATIONS

• Member, American Society for Quality (ASQ)
• Member, Parenteral Drug Association (PDA)