PRTR Recruitment Co., Ltd.

ดูรายละเอียดบริษัท

14 พ.ย. 67

Quality Specialist (นนทบุรีติดกับปทุมธนานี)

สถานที่ปฏิบัติงาน

อ.ปากเกร็ด จ.นนทบุรี

เงินเดือน

30,000 - 43,000

อัตรา

สมัครงาน

บันทึกงานที่สนใจ

พิมพ์

แชร์

รายละเอียดงาน

- Monitoring the overall quality of the product. - Implementing cGMP. - Giving required training to all new as well as existing employees. - Implementing ISO and Quality Management System standards. - Conducting internal quality audit. - Following up on audit NCs and responsible for clearance of audit NCs well within time. - Communicating with external agencies for calibration and validation. - Ensuring validation of the process. - Preparing dossier for submission to the regulatory authorities. - Coordinating with the complaint team for the investigation. - Reviewing and approving documents. - Ensuring proper implementation of the CAPA. - Being involved and providing feedback on any root cause investigation. - Ensuring dispatch verification. - Releasing batch based on the review of test results. - Performing supplier audits. - Archiving and preserving as per the document control procedure.

คุณสมบัติผู้สมัคร

Minimum 2 years’ experience in the medical device/ pharmaceutical industry is an advantage.
Bachelor's degree in Pharmaceutical/Medical technology, engineering or related field.
Working knowledge of ISO 13485 and 9001.
MS Office and mechanical drawing software are required.
Fluent in written and spoken English.