Experience : 15 - 20 years in API/Chemical/Food industry

1. Ensure Compliance :

- Developed and implemented quality control methodologies to ensure compliance with quality assurance standards, guidelines and procedures in each assigned tasks.

- Developed and conducted audit scheme to ensure compliance with medical device regulations while eliminating the need for corporate auditing support.

- Recruited, trained and provided guidance to Internal Auditors to ensure compliance with the quality management system and organizational requirements.

- Supported in new product introduction process to ensure compliance to quality systems and successful integration of new products into operations.

2. Batch Records :

- Examine Production, Packaging batch records and labels before release.

- Develop and implement procedures and batch records for production.

- Review and approve batch records from daily production.

- Review completed batch records, Environmental Monitoring data, laboratory records and other ancillary data for product release.

3. QA :

- Recruited to corporate staff position for manufacturer of concrete products to develop and implement standardized QA program across four manufacturing plants.

- Standardized QA functions worldwide by establishing a Corporate Quality Assurance Department; determined policy and implemented globally to 10 overseas offices.

- Conduct QA-Automation vendor procurement and helping to set up automation integrated environment, define automation methodology the entire organization.

- Process Redesign and Optimization of internal and corporate QAPI and risk management database designs systematic processes and systems assessments.

4. GMP :

- Perform Quality/GMP/GDP related processes and support staff in a bilingual environment with a broad variety of regulatory and compliance requirements.

- Develop and co-ordinate GMP training program for QC, Manufacturing and Development personnel to include documentation and evolution of effectiveness.

- Directed and coordinated quality and regulatory affairs activities to support new product development, improving GMP compliance.

- Performed audits for GMP compliance and implemented changes to quality systems to exceed minimum regulatory requirements.

5. Finished Product :

- Develop, apply, revise and maintain SOP and quality standards for in- process data and finish product.

6. Product Quality :

- Investigated customer complaints associated with product quality and coordinated the development of root cause analyses and the development of corrective actions.

- Establish procedures for maintaining high standards of product quality, reliability and safety and facilitated multiple process and continuous improvement projects.

- Deliver quality controls and enhancements to proactively address problems while improving product quality, manufacturing productivity, customer satisfaction and revenue.

- Developed the specific quality programs that provided the appropriate level of product quality and reliability, customer service and customer satisfaction.

7. Quality Standards :

- Develop, implement, promote and monitor safety and quality standards to reduce and eliminate risks and improve organizational performance.

- Provide timely and accurate quality information to the appropriate departments and personnel in order to achieve desired quality standards of products.

- Managed and improved the Quality standards for a safety footwear manufacturer specializing in a variety of firefighter, and industrial products.

- Maintained product integrity by ensuring parts provided to manufacturing met quality standards for engineering specifications, including ISO standards.

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