Shahla Faizi

Operations Associate

Melbourne, Victoria, Australia24 yrs 9 mos experience

Highly Stable

Key Highlights

Achieved zero critical audit findings in three years.
Boosted employee satisfaction by 36% through mentorship.
Reduced microbiology cycle time by 55%.

Stackforce AI infers this person is a Quality Control Manager in the Pharmaceuticals industry with a focus on regulatory compliance and operational excellence.

Contact

Skills

Core Skills

Quality Management SystemsGmp ComplianceOperational Excellence

Other Skills

Strategic InfluenceProcesses DevelopmentGMPDigital Quality SystemsLean ManufacturingData-Driven InitiativesCommunicationRoot CauseRegulatory ComplianceCAPAGLPStability TestingRaw material testingSales Strategy & PlanningAccount Management

About

As a Senior Manager of Quality Control at Pfizer with over three years in this role, I bring proven expertise in GMP compliance, regulatory standards, and quality systems, consistently achieving zero critical audit findings while driving operational transformation. I have led the implementation of digital quality systems, improved laboratory efficiency, and cultivated a culture of quality excellence. With more than 20 years of experience in Quality Control, I combine technical expertise with strong leadership, team building, public speaking, and emotional intelligence. I am passionate about developing high-performing teams, empowering individuals to excel, and fostering a culture of collaboration and innovation. My mission is to uphold regulatory compliance while delivering operational excellence and supporting employee wellbeing. Outside of work, I actively present and encourage students in schools and universities to explore STEM fields and build successful career paths. Together with the support of my family, I successfully established a school in a disadvantaged country, providing education for over 400 students and supporting its ongoing costs, helping create opportunities for the next generation of learners.

Experience

24 yrs 9 mos

Total Experience

6 yrs 2 mos

Average Tenure

Current Experience

Pfizer

3 roles

Senior Manager Quality Control- Chemistry and Microbiology

Promoted

Jan 2022 – Oct 2025 · 3 yrs 9 mos

Provided strategic leadership across Quality Control Chemistry, Microbiology, and Laboratory Equipment, overseeing Process Validation, Stability Programs, and Raw Material release in a 24/7, 3-shift environment, ensuring compliance with global regulatory standards (TGA, FDA, EMA, MHRA, ICH, and others). Built a culture of quality excellence, achieving zero critical audit findings over three years.
Led operational transformation through lean, data-driven initiatives and digital quality systems (LIMS, MODA, eQMS), enhancing compliance, efficiency, and productivity while strengthening DI & computerised systems via robust lifecycle management, access governance, backups, & cybersecurity.
Represented laboratory operations at executive and external forums, influencing strategic decisions through performance, risk, and compliance insights, supporting successful inspections, sustained global compliance, business-critical approvals, and strong stakeholder confidence.
Restructured QC to improve collaboration, balance workloads, and create career pathways, championing wellbeing, diversity, and inclusion to develop future leaders. Provided targeted coaching and strategic support to SMEs, ensuring confident, compliant, and effective presentations during inspections and audits.
Key Achievements:
Maintained zero critical findings across audits and inspections, demonstrating robust quality systems.
Boosted employee satisfaction by 36% through restructuring, mentorship, and engagement programs
Reduced Microbiology cycle time by 55% (56 → 25 days)
Cut stability testing costs by 50% via optimised testing points and strategic partnerships.
Improved CAPA, investigations, and change control compliance by 40%, strengthening regulatory adherence.
Increased Lab capacity by 20% through product and method transfers.
Reduced process waste by 30% through risk-based CI
Delivered strategic coaching to site SMEs during inspections and audits, enabling confident, compliant presentations

Strategic InfluenceProcesses DevelopmentGMPDigital Quality SystemsOperational ExcellenceQuality Management Systems+1

Chemical Quality Manager

Promoted

Jan 2016 – Jan 2022 · 6 yrs

Provided strategic leadership for QC Chemistry operations, managing a high-performing team responsible for testing, analysis, and regulatory compliance. Drove operational excellence, implemented robust quality systems, and collaborated with cross-functional teams to ensure alignment with GMP and global regulatory standards.
Key Achievements:
Successfully represented the department to FDA, TGA, and other regulatory agencies with zero major observations.
Streamlined investigations and CAPA processes, reducing risk and ensuring timely corrective actions.
Optimized laboratory operations, improving efficiency, turnaround times, and overall productivity.
Led the deployment of the Integrated Manufacturing Excellence (IMEx) program across QC Chemistry and supported cross-department adoption.
Achieved a 75% reduction in QC Chemistry deviations, demonstrating measurable quality improvements.
Developed and mentored the team through training programs that enhanced analytical capabilities and laboratory competencies.

CommunicationRoot CauseGMPRegulatory ComplianceQuality Management SystemsGMP Compliance

QC Chemistry Co-ordinator

Jan 2015 – Jan 2016 · 1 yr

Provided critical coordination support to Chemistry Quality Control operations, ensuring accurate sample analysis, adherence to protocols, and compliance with global regulatory standards (GMP, FDA, TGA). Played a key role in optimizing lab workflows, maintaining equipment reliability, and supporting the implementation of innovative testing methodologies to enhance overall QC efficiency.
Key Achievements:
Streamlined sample tracking and analysis, reducing turnaround time by 50% and improving productivity.
Maintained laboratory compliance with GMP, FDA, and TGA standards, supporting successful audits and inspections.
Implemented new testing methodologies, enhancing the efficiency and reliability of Chemistry QC processes.
Ensured accurate results through equipment maintenance and calibration, supporting consistent quality output.
Contributed to robust documentation and record-keeping, reinforcing regulatory readiness and data integrity.

CAPARoot CauseGMPRegulatory ComplianceQuality Management Systems

Hospira

3 roles

QC Chemistry Co-ordinator

Jan 2014 – Jan 2015 · 1 yr

Provided essential coordination support for Chemistry Quality Control operations, ensuring accurate sample analysis, adherence to protocols, and compliance with global regulatory standards (GMP, FDA, TGA). Facilitated optimized laboratory workflows, maintained equipment reliability, and supported the rollout of new testing methodologies to enhance overall QC efficiency.
Key Achievements:
Streamlined sample tracking and analysis, reducing turnaround time by 50% and increasing laboratory productivity.
Ensured ongoing compliance with GMP, FDA, and TGA standards, contributing to successful audits and inspections.
Supported implementation of new testing methodologies, improving efficiency and reliability of QC processes.
Maintained equipment accuracy and calibration, supporting consistent, high-quality results.
Contributed to robust documentation and record-keeping, reinforcing regulatory readiness and data integrity.

CommunicationCAPAGMPRegulatory ComplianceQuality Management Systems

QC Chemistry Team Leader

Promoted

Jan 2013 – Jan 2014 · 1 yr

Led a high-performing QC team in Chemistry operations, ensuring GMP and global regulatory compliance. Drove process improvements, streamlined workflows, verified raw data, and enhanced data accuracy, while fostering a collaborative, accountable, and high-engagement team culture. Mentored team members, supporting career growth and developing future leaders.
Key Achievements:
Consistently met or exceeded QC performance targets.
Reduced sample turnaround times and improved lab efficiency.
Boosted team engagement and retention through mentorship and inclusive leadership

GMPCAPAQuality Management Systems

Senior QC Analyst

Jan 2009 – Jan 2013 · 4 yrs

Led complex data analysis and reporting initiatives to drive QC process improvements and operational efficiency. Collaborated with cross-functional teams, mentored junior analysts, and provided actionable insights for decision-making and regulatory compliance. Played a key role in process standardization and digital system implementation.
Key Achievements:
Developed and implemented data-driven workflows that improved laboratory efficiency and accuracy.
Supported regulatory inspections by providing precise analytical data and documentation.
Mentored junior analysts, improving team competency and knowledge sharing.
Contributed to process optimization projects that reduced cycle times and improved productivity.

GMPGLPQuality Management Systems

Mayne pharma

QC Analyst

Jan 2003 – Jan 2009 · 6 yrs

Supported QC operations by performing data analysis, generating reports, and ensuring accurate documentation to maintain regulatory compliance. Monitored key performance metrics, assisted in process optimization, and collaborated with cross-functional teams to enhance operational efficiency.
Key Achievements:
Streamlined reporting and data tracking, reducing turnaround time for analysis by 30%.
Assisted in implementing new testing methodologies, improving laboratory efficiency.
Maintained accurate records and documentation to ensure GMP and regulatory compliance.
Supported investigation and CAPA processes through detailed data analysis and reporting.

Stability TestingRaw material testing

Lux pty ltd oakleigh vic

Sales Consultant

Jan 2001 – Jan 2003 · 2 yrs

Delivered consultative sales solutions by understanding customer needs, presenting tailored products/services, and building strong client relationships. Leveraged market insights and product knowledge to drive revenue growth while ensuring customer satisfaction and loyalty. Collaborated with cross-functional teams to optimize sales strategies and achieve business objectives.
Key Achievements:
Consistently achieved or exceeded sales targets, contributing to overall business growth.
Developed and maintained strong client relationships, increasing repeat business and customer retention.
Provided consultative solutions, matching customer needs with appropriate products/services.
Identified market opportunities and recommended strategies that enhanced sales performance.
Delivered product presentations and demonstrations that increased customer engagement and conversion rates.

Sales Strategy & PlanningAccount Management