1. Check production documents and control quality. For information on approval of ready-made drugs for sale
2. Supervise the quality assurance system of the products.
3. Approve results of remediation of nonconforming products.
4. Approve the results of corrective and preventive actions for product defects.
5. Supervise and be responsible for the Quality Control Department instead of the QCM when the QCM is unable to perform its duties.
6. Supervise employees to comply with GMP rules.
7. Supervise employees to comply with the policy. Operating procedures and requirements of the company's various management systems.
8. Approve documents in various management systems of the company.
9. Overseeing the management of drug return, drug recall and customer complaints.
10. Administering the Validation Master Plan
11. Supervise the NCR system and change control.
12. To audit according to various management systems.
1. Manage, control and approve the development of document systems that meet the quality assurance system and improve quality.
2. Contact and coordinate with the Audit team from outside organizations and consulting on quality systems with all departments that want to be audited.
3. Prepare the quality system of all departments to receive the audit such as the inspection area, responsible person, documents, etc.
4. Planning and auditing both internally and externally explain the issues according to the facts and correct them according to the quality document.
5. Follow up the operations of all units in accordance with the planned quality system. Maintain a standard system
6. Follow up on the progress in correcting, preventing or taking action according to the guidelines proposed to the Audit team.
7. Track the deviation of the quality system. And the quality document system to be in accordance with the original standards are reviewed regularly.
8. Collect data and make quality reports. To conclude, at the meeting and report to the Managing Director.
1.Handle incoming raw material process and check quality issue of raw material.
2.Plan and manage for inventory management and product delivery as sales order.
3.Plan, assign and control production team to work as plan and meet the target.
4.Responsible for cutting work planning and controlling cutting machine operation process.
5.Plan and purchase tools and part of machine for production process.
6.Collaborate with Sales team and Administration team
7.Responsible for scrap and waste process of warehouse.
8.Responsible for warehouse management, facilities and company area.
9.Handle for safety and occupational task for production process and warehouse.
10.Collaborate and cooperate for Quality management system jobs.
11.Responsible for planning and controlling staff of Production team.
12.Training production staff related production work and cooperate with HR.
13.Communicate company direction and policy to Production team.
14.Coordinate with Administration team for HR&GA jobs.
16.Warehouse and production process
1.Planning and organising production by scheduling and assigning daily job duties to workers.
2.Provides manufacturing information by compiling, initiating, sorting, and analyzing production performance records and data; answering 3.questions and responding to requests.
4.Manage and provide job training to workers to meet production goals.
5.Maintains safety and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
6.Ensure that final product meets quality standards and customer specifications.
7.Monitor productivity rates and product resources that are required and ensure stock levels remain adequate.
8.Manage the workflow by assigning responsibilities and preparing schedules.
9.Perform verification of production output according to specifications.
10.To be responsible for other duties provided by superiors.
• Perform and manage the product license registrations and other regulatory licenses with FDA and other authorities in assigned countries for both IMPORT and EXPORT products.
• Works independently to analyze and evaluate the requirements of new products SUCH AS formula checking, and review registration documents and able to address the gap of deficiencies.
• Review product label/artwork for compliance with regulations.
• Responsible for all documents related to FDA.
• Responsible for Cosmetic Product Information File (PIF) preparation.
• Submit License per invoice (LPI) for product sample.
• Provide regulatory advisory and address all inquiries to the related team; research and innovation, sales and marketing team, and etc.
• Maintain up-to-date registration records and provide status to business on regular basis.
• Keep update and maintain the knowledge and awareness of current applicable regulations and standards, and identify trends which may have an impact on the business.
• Manage department of the packaging design team to accomplish assigned target by CEO
• Improvement of working process and technical knowledge and training staff
1. Packaging Development
1.1 New package development based on customers' requirements and considering factory's production feasibility
1.2 Coordinate with all related parties on project updates and feasibility. generating new concepts, providing technical and cost assessment
1.3 To liaise with international packaging suppliers for new packaging sourcing and packaging development in order to meet customers product requirements
1.4 Problem-solving technically and implementing package and finished goods specifications
2. Sourcing Packaging
2.1 Seeking the new suppliers for both of Skincare and Makeup, Meeting with oversea and local suppliers. Secure good suppliers in terms of cost, quality, lead time, and service
2.2 Collaborate with sale team and client on generating new concepts, and provide technical and cost assessment
2.3 Technical review to source new pakcage
2.4 Detail design of components to meet good quality as finished goods
3. Negotiation and Communication
3.1 Coordinate with cross-functional teams (QA, R&I, Production team, HQ and overseas branches) to meet on-time delivery
3.2 To negotiate on price, lead time, and other subjects with suppliers and partners with responsible departments to ensure all projects and delivered on-cost, on-spec, and on-time
4.1 To manage and control each packaging project timeline, to achieve the projects' deadline
4.2 To handle costing and technical objections
4.3 To provide problem resolving technically, to deal with customer complaints and supplier controls
4.4 To monitor efficiency and improve work process - conducting packaging database and report
4.5 Take the lead in developing detailed packaging and finished goods specifications including standard sample, range board
4.6 Training design team staff & evaluation
4.7 Other jobs as assigned
- Check the Drawing and Approval sheet of the product as requested by the customer
- Take care of product problems, quality control system, supervise the management of the quality department and develop efficiency
- Manage plan, Provide quality information to customers
- Report the results to the management.
- Coordinate according to various management systems to achieve the goal
1.Colloect the Overall activities of incoming &outgoing quality functions.
2.Controlling in all action decreasing an internal defect.
3.Preparation of QA reports to head of department.
4.Other task as assigned.
- Collaborate with regulatory and cross-functional colleagues on clinical document reviews
- Provides support in the preparation of regulatory submissions for investigation and commercial products in line with FDA requirements, regional requirements, and scientific and company policies and procedures
- Successfully handle routine labelling changes and drug listings
- Performs work-flows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department
- Keep up to date with changes in regulatory legislation and guidelines
- Offer advice about company policies, practices and systems
- Support analysis/activities/communications from RA perspective on product complaints, adverse events, and field actions, etc.
-Control, check, and monitor product quality to ensure all products comply with the company standards.
-Organize and manage QC teams to achieve the KPI targets and the organization goals.
-Control and maintain all ISO requirements in the plants.
-Focus on customers' requirements and support sales team.
-Review and approve manufacturing instructions for adequate points of inspection operations and supervise conduct quality control reviews.
-Verify and maintain quality control records.
-Recruit, train and support quality personnel to assure effective and competent performance of quality functions and promote employees’ positive moral.
-Support in reviewing all manufacturing, purchasing and test documentation to ensure conformance to the standards of QC.
-Report serious or repeated failures or unreliability in quality of products.
-Recommend appropriate corrective actions or plans/programs to minimize defects in products.
-Perform other quality assurance functions as necessary or as requested.
-Cooperate internally with the production, sales & marketing and related departments.
-Coordinate externally such as dealing with customers and suppliers on quality or performance issues.
-Continuous improvement and optimization of the process quality control system to ensure delivery of product quality to customer satisfaction.
-Complete other tasks assigned by the superior.
Supervise QC staff level and train new members
- Check the quality of the products before the products are shipped out by using EDX
- Make a report of the QC
- Prepare documents: SC, WI/SOP, PPAP,LIT,SC
• In charge of QA/QC activities/tasks to ensure that the company's products are met with the given standard
• Audit and test the quality of the product produced according to the regulations and the standard
• Follow up and take care of complaining cases from clients regarding the defect of the products
• Handle all QA/QC reports
• Other assigned tasks by the supervisor
1.Coordinate with Yamaha subsidiaries in ASEAN region for Regulation & Certification of motorcycle business.
2.Research and update Regulation & Certification system, workflow, tools and database in ASEAN countries.
3.Analyze ASEANautomotive policy and trend as well as report to management for strategic decision making.
4.Monitor movement of ASEAN automotive regulation about ICE and Electrical Motorcycle for negotiating with the government and industrial group for Yamaha’s profit.
5.Participate in ASEAN conference, Government meeting and Industry meeting of Regulation & Certification issues and activities.
6.Day-to-day liaison with motorcycle certification process and good understanding of related government authority system.
7.Cooperate and lead activities in order to improve Yamaha’s group perception on Regulation & Certification.
Planning, Control about new Resource and Development by manage improving production process in order to response customer requirement by internal and external including production process improving and setting as well.
*Responsible for New product flow : Design model and test prototypes for customer requirement, Process trial ,Pre-mass confirmation, Mass improvement quality and productivities, Standard issue, Training or any related field.
*Create, Design and Manage for new machine, tool and packing.
*Contact to internal and external suppliers or institutes for outsource design and development.
*Improve product design to meet customer requirements
*Cooperate with Production team, Production planning team and Quality team, Sale team, Purchase team, Maintenance team to solve any problem.
∎Production Control Role:
1.Check and monitor quantity of raw materials and other auxiliary to ensure that are sufficient for process and comply with standard of specification.
2.Support superior in managing and monitoring all production activities and parameter which effects to production process to ensure that production run as the plan set and MPS target set is achieved.
3.Analyze and provide solution against a problem in production process to prevent consecutive impact on other processes.
4.Coordinate with Maintenance & Reliability Team regarding maintenance plan to ensure that maintenance activities prepared for production can be completed within timeline and equipment are in operational condition.
5.Coordinate with Supply Chain team to firm the production schedule and communicate any deviation from the plan.
6.Check and monitor production data e.g. logbook, batch reports, usage sheets, chemistry data, shop orders, etc.
7.Supervise team members in shift to ensure that all process parameters are under control as plan.
8.Prepare shift reports and communicate to next team on duty to ensure that necessary information is communicated effectively.
∎Commissioning/Startup activities for Project Role:
1.Support special operation projects in term of training, preparation, commissioning, start-up and documentation to ensure the project completed within timeline and safely manner.
2.Involve in plant commissioning and startup activities of MOC/production expansion as well as ensure operational process.
3.Support in troubleshooting against any issue occurred during pre-commissioning, commissioning and startup.
4.Ensure that related operational procedures are available and communicated to team members
∎People Management Role:
1.Monitor adequacy and readiness of shift members to ensure that skilled staff on duty are enough for controlling production process.
2.Supervise production team in shift to ensure that all staff are complied with company rules and regulation.
3.Involve in evaluating shift staff and conducting development in line with the plan.
4.Encourage and motivate staff to involve in other production support activities.
*Control quality of welders
*PIPING - Check Material for DWG.
*Inspect and mark the welding spot
*Recommend and checking the WELDMENT
*Send RT (in the case of the result RT is REJECT, you must mark the point where REPAIRE to the welder)
*PIN HOLE TEST for the part of U / G or F / L
*Control GA, P&ID, ISO MATIC formulas that correspond to reality.
*Operation for the KPI if the company and department and join the activity 5S
*Monitor and control all aspects of new product development ,Improve product are followed.
*Product design ,Process design ,Tooling design ,Material selection and all concern parameters
*Must be applied in development or improvement process from initial phase to implementation ,Production and final phase at customers
*To cooperate with customer, Parent Company, supplier and other departments
*To control, support and follow up subordinates in works for the development.
*To control product specification, material specification, Closure drawing and technical information