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สิ่งที่ผู้หางานคนอื่น ค้นหาเพิ่มเติม

28 ตุลาคม 2563
รหัสงาน: CHC-3379
Quality Control Manager (QA & RA)

QA&RA Manager:

  • 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 in regards to 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. 

Quality Control Manager:

  • 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 are in compliance with 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 analyze 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.

Qualifications:

  • Bachelor degree of Pharmaceutical science
  • Experience 3 – 5 years in Pharmaceutical industry.
  • Understanding in area of GMP/GSP/GDP principle.
  • Knowledge of relevant regulation and guideline.
  • Knowledge of pharmaceutical regulatory company requirement.
  • Good communication skills including in English (both written and spoken).
  • Problem solving skill.
  • Interpersonal skill.
  • Analytical skill.
  • Computer skill; MS. office

รายละเอียดงาน:

สวัสดิการ
  • เงินโบนัสตามผลงาน
  • ค่าใช้จ่ายในการเดินทาง
  • ประกันสุขภาพ

Devakam Osoth Co., Ltd.
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