Quality Assurance

To perform quality assurance functions including QC record/batch record review, product release, investigations, waivers, audit support and customer complaints.

Responsibilties:

1. Quality Management System

• Can perform all responsibilities associated with Quality Assurance System
• Develop and evaluate new or revised procedures using methodology and in-depth understanding of all procedures in the QA system, Ensure documentation and records are maintained according to plant procedures and the quality system Support associated with Quality Assurance System, ISO 9001, FSSC 22000, cGMP & HACCP.
• Control and maintained plant quality document
• Monitor plant KPI.
• Responsible for Kosher, Halal certificate.
• Responsible for MOC coordinator for product quality change.
• Responsible for Internal Audit activity, CAR follow up.
• Customer Audit Support – Compile quality and manufacturing records and conduct complete batch review for customer audits.  Respond to related audit findings;
• Customer complaints – Provide support as needed to document, track and maintain customer complaints in plant and sale force complaint systems. Contact customer, lead investigations, determine root cause and corrective/preventive action.  Follow up with customer and respond to customer in writing.  Summarize and communicate results to Sales and plant;
• Supplier Audit– Can perform the supplier audit, to maintain the quality of critical materials.

2 cGMP & HACCP/FSSC2200

• cGMP – Monitor cGMP control program.
• HACCP – Establish HACCP Program and evaluate performance of Food safety system.
• Provide the training of Basic ISO/cGMP & HACCP/FSSC22000 course and related Food safety &Quality course, new rule & regulation.
• Participate in the training of new employee.
• Maintain pest control program by coordinating and reviewing weekly inspections performed by contractor. Follow up on any non-conformances identified and ensure that corrective actions are being taken
• Support Food safety & Quality recognize activity.    

3 Quality Assurance 

• Review Batch record, quality testing results prior release.
• Set up COA profile of all SKU in SAP.
• Responsible for maintain internal specification and update sale specification.
• Represent quality on plant business point teams, quality improvement teams and other meetings to address quality issues and provide QA perspective.  Work with engineers, operators and other team members to complete projects;
• Ensure all testing, reporting and product release is in alignment with quality system;
• Ensure documentation and records are maintained according to plant procedures and the quality system;
• Define and optimize quality assurance procedures to maximize efficiency while maintaining high compliance to standards; train personnel as necessary.
• Follow up all nonconforming product/Material.
• Recall coordinator, support quality manager.
• Right First Time Report – Calculate and report Right First-Time quality figures to plant and divisional personnel.
• Provide Monthly report.

4 Regulatory & Compliance

• Provide local food safety regulation information and respond to all responsible department. in timely and complete manner;
• Provide the related documents for FDA license submission.
• Ensure all activity and product quality conform with both of Thai and customer’s country regulation
• Comply with external and internal requirements and regulations (DuPont, OSHA, cGMP&HACCP, ISO 9001, FSSC 22000etc).
• Coordinate with FDA officer, Regulatory affair and related .
• Monitoring and update the related regulation

5 Saefetly/Health/Environment

• Ensure all operations are carried out in accordance with safety, EHS policies and practices
• Participate in site safety programs, behavioral based safety activities, audits and emergency response activities as required.

6 Administration/Financial

• Ensure cost conscientious is a major consideration in utilization of laboratory materials and equipment;
• Ensure correct purchasing procedures are followed when purchasing goods or materials on behalf of the company.
• Support Manager in the budget process by providing information as required.

Qualifications:

• Minimum Associate’s Degree with Bachelor of Science Degree preferred in Food technology, chemical technology, microbiology, or related fields of study or equivalent combination of education and experience;
• 5-7 years experience in Quality& Food Safety system management, analytical, microbiology lab, quality control in Food Manufacturing or Pharmaceutical
• Experience with basic laboratory equipment and analytical testing procedures;
• Experience with microbiology protocols and biohazards.
• Experience with Quality System management ISO 9001, cGMP & HACCP, FSSC 22000, pharmaceutical quality management and EXCiPACT is preferred.
• Formal statistical training and demonstrated ability to apply statistical techniques to laboratory methods and plant processes;
• Demonstrated ability to apply chemistry concepts to solve problems;
• Knowledge of QC techniques and experience with ISO9001, cGMP & HACCP, FSSC 22000.and USP quality requirements relative to pharmaceutical excipients and food additives;
• Excellent computer skills and software knowledge, including proficiency in programs such SAP, Microsoft Office.
• Highly organized and self-motivated;
• Ability to work in a fast-paced environment while maintaining quality requirements and meeting deadlines;
• Excellent interpersonal skills.  Ability to function both as a leader and a team player;
• Strong oral and written English communication skills.  Ability to effectively communicate at various levels of the organization, with demonstrated attitude of respect towards others;
• Overtime and occasional weekend work as required to complete testing and projects in accordance with business and customer demands.
• Preferred candidates who current address is in Chonburi, Rayong province