Results-driven Quality Assurance and Manufacturing Professional with extensive expertise in GMP, cGMP, QMS, and compliance within the pharmaceutical and food manufacturing sectors. Proficient in validation, audits, regulatory oversight, risk management, and leading continuous improvement initiatives. Demonstrated success in navigating FDA, TGA, APVMA, PIC/S, ICH, and ISO standards while managing quality systems and conducting audits to ensure compliance excellence. Renowned for exceptional problem-solving skills, meticulous attention to detail, and a steadfast commitment to maintaining consistent product quality.
Key Achievements:
To ensure SalDoce Fine Foods meets the appropriate quality assurance standards to
produce its products and its customers’ requirements.
To develop new and re-engineer existing products under the SalDoce brands.
SalDoce Quality Assurance Manual - HACCP
- Review and working towards improvement of current SOP's
- Ongoing implementation of HACCP program
- Develop HACCP version covering
• Production
• Customer Complaints
• Supplier Register
• Testing (baking /cooking of products)
Product Development / Specifications
- Detail product specifications for all products manufactured
- Creating specifications for all new products developed
- Managing product development projects
• Testing
Production / Co-Packers
- Ensure co-packers are producing products to required quality standards
• Approving retention samples packaging
• Approving and testing retention samples
• Audit of co packers
- Managing production forms from co-packers
• Resolved issues efficiently and
Inspected finished products for quality and adherence to specifications
• Prepared batch card of day-to-day production processes
• Maintained organized work area by cleaning and removing hazards
• Carried out day-to-day duties accurately and efficiently
• Followed safety processes and protocols while moving powder and operating heavy
machinery to avoid accidents
• Participated in team-building activities to enhance working relationships
• Proved successful working within tight deadlines and fast-paced atmosphere
• Operated various tablet compression and capsule filling machine (ZP15 automatic
rotary pill tablet press machine, ZP 55 automatic rotary tablet press) and Capsule
machine (NJP-3800C Capsule filling machine).
Gathered, arranged and corrected research data to create representative graphs and
charts highlighting results for presentations
• Validated incoming data to check information accuracy and integrity while
independently locating and correcting concerns
• Researched and interpreted large volumes of scientific data and literature
• (Assisting team with review of scientific content for Chinese or other herbal
ingredients, as well as providing evidence through generation of data via research
papers or studies)• Supported research and development efforts to create new products and processes
• Helped team meet regulatory requirements by coordinating documentation and filings
• Supported lab activities by maintaining inventory and chemical stocks and cleaning
lab equipment
• Planned, modified and executed research techniques, procedures and tests
• Maintain and review quarantined products for stability and keep track of results.
Generated quality control reports for returned products to identify and communicate
patterns.
• Supported audit preparation through research, analysis and presentation
development.
• Educated employees on specific QA standards and confirmed maintenance of
standards.
• Fixed identified issues to increase productivity and boost workflows.
• Provided regular updates to team leadership on quality metrics by communicating
consistency problems or production deficiencies.
• Assessed quality of finished products with careful inspections.
• Communicated quality issues with Drug ferrous sulphate and folic acid tablets I.P
promptly.
• Maintained neat, tidy work environment in GMP area and Manufacturing facility.
• Maintained batch records for compliance and analysis purposes.
• Performed standard first article inspections and random sampling inspections to verify
adherence to customer standards.