SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supplier Scorecard ratings and vendor audit to ensure the vendors adhere to the regulatory requirements and to investigate, analyze and resolve supplier quality problems * Extensive experience in managing the Supplier Quality metrics such as: Non-Conformance Tracking (MRB) Supplier Corrective Action Requests (SCAR) Corrective Action and Preventive Action (CAPA) * Extensive experience in Validation from the Process Design Plan through the completion in accordance with cGMP's (IQ, OQ and PQ) * Extensive experience in product development projects, including validation plans, verification of the label and stability studies * Extensive experience in Risk Analysis, Gantt charts, Statistical Sampling Plan and Mistake Proofing/Poka Yoke. * Extensive experience on Root Cause analysis methodology and implementation of Corrective and Preventive Actions (CAPA) * Extensive experience in reducing customer complaints by thorough Root Cause Investigation and developing and implementing a robust Corrective and Preventive Actions (CAPA) * Extensive experience in Food safety plan, allergen handling and control, and HACCP plan * Extensive experience managing the activities of the Incoming Quality Control (IQC) department to ensure incoming raw materials, components and contract manufactured products meet their approved specifications or other regulatory requirements * Extensive experience in managing the internal quality and housekeeping audits to assure manufacturing facility conforms to regulatory standard and manufacturing requirements * Extensive experience in managing quality teams, processes, and initiatives to drive continuous improvements, better quality control and production efforts * Extensive experience managing calibration program to ensure that all equipment's that require calibration are calibrated on timely manner and adhere to regulatory requirements * Extensive experience in Quality activities for development, design, distribution and/or manufacturing of various products to ensure high level of process and product quality regarding Pharmaceutical, Medical Device, Food industry, Nutritional, and Skin Care products * Extensive experience in FDA Guidelines, US Pharmacopoeia -NF and other approved International standards * Extensive experience for real time and accelerated stability study * Extensive experience in problem-solving and troubleshooting skills. Proven ability to exhibit an energetic, positive, approach to teamwork

Highlights:

• Extensive experience in CAPA
• Extensive experience in IQ/OQ/PQ VAlidation
• Extensive experience Quality audit
• Extensive experience Supplier Qualification
• Extensive experience FDA and ISO Regulatory
• Extensive experience Process and Quality improvement
• Extensive experience Reducing customer complaint
• Scheduling
• Chemistry
• Good Manufacturing Practices