Manager - Quality Audit - API/Chemical/Food Industry (15-20 yrs)
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.