หน้าที่ความรับผิดชอบ

1. QA/RA - Pharmacist

-Develops, establishes, and maintains the QA programs, policies, and procedures to ensure GMP compliance.

-Handle activities related to quality assurance including internal audit, product quality review, change control, deviation control, product complaint, recall and return, GSP/GDP requirement, batch release.

-Write, review, analyses, and revise written standard operating procedures (SOPs) and submit procedural changes as needed.

-Develop plans to investigate identifies risks and implement corrective action plans (CAPA)

-Manage and support the qualification and validation system. 

-Assist in developing or updating quality management system procedures and participate in internal or external audit.

-Responsible for document management systems. 

-Ensure that all staffs are trained regarding quality standards.

-Cooperate with other departments to establish the quality system for control the legal compliance and operates to maintain a state of control.

-Management of the product registration and life cycle management of local and export products.

-Prepare the registration dossiers (ACTD), variation applications and all other regulatory document required by Thai and relevant FDA.

-Ensure timely regulatory submission upon internal review and approval.

-Check and approve accuracy of product artworks and related materials to comply with regulation.

-Prepare annually mandatory report according to FDA regulations and other regulatory affairs tasks including the post-marketing requirement.

-Maintain current regulatory knowledge of guidelines, regulations, and standards in all countries that the company is exporting to and apply appropriate implementation strategy.

-Others assigned

2. Quality Control - Pharmacist

-Establish quality procedures, standards, and specifications for a company

-Collaborate with an organization’s purchasing manager to ensure raw materials from external suppliers meet quality requirements

-Set and enforce standards for health and safety during work operations

-Carry out research to identify ways to reduce waste and maximize resources

-Ensure manufacturing processes follow both national and international standards of production

-Conduct surveys to identify customer requirements and ensure they are being met by established quality standards

-Proffer recommendations to company management on ways to improve on existing quality processes

-Collect, compile, and analyse relevant quality statistical data to obtain information regarding quality performance

-Supervise technicians, inspectors, and other company staff to ensure they perform their duties in line with established quality procedures

-Monitor product development processes to identify deviations from quality policies

-Conduct tests to verify the quality of raw materials and finished products

-Review existing process and product specification to identify the need for improvement or upgrade

-Approve compliant products and reject defective ones

-Prepare and present reports to update upper management on quality activities

-Maintain proper records of quality test, procedures, and standards.

-Others assigned

3. Production - Pharmacist

-Control the production and packaging of modern and traditional medicines in accordance with the planned work plan.

-Arrange the number of employees to suit the production capacity and daily production.

-Solve problems that arise in the production process and determine a solution if the results do not meet the goals.

-Provide standard time for production of products, collect data and report KPIs. production department

-Plan employee development and follow-up and evaluate the development of production staff together with the production manager.

-Liaise and coordinate with various related departments such as the collection of various consumables.

-Check the initial production documents. before sending to the production manager

-Check raw material weighing, mixing, packing, and packaging of modern and traditional medicines together with the production manager.

-Make a quality system such as GMP/PICS, ISO 9001/2015 together with the production manager.

-Together with the production manager to prepare the annual budget that will be required of the production department.

-Control all expenses of the production department, take care of order or 5S.

-Teach the work to the head of the room and the production staff. together with the production manager

-Coordinate with various departments. to meet the production plan

-Responsible for production processes in the department to meet GMP/Picks standards.

-Others assigned