āļĢāļēāļĒāļĨāļ°āđāļāļĩāļĒāļāļāļēāļ**Main duties, responsibilities, and authorities (āļŦāļāđāļēāļāļĩāđ, āļāļ§āļēāļĄāļĢāļąāļāļāļīāļāļāļāļāđāļĨāļ°āļāļģāļāļēāļ):
-Responsible to monitor all activities carried out related to product quality.
-Deliver solution to product sustaining issue.
-Responsible for Data analysis
-Handling of test batch request for the new processes and for trouble shooting.
-Gap analysis of QA related documents.
-Responsible for in process Quality checks
-Installation and calibration of machines and trouble shooting
-Preparation of process validation protocols and reports
-Raise CDCR/Change control for implementation of Quality processes
-Responsible for collecting data for PMS and prepare PMS report
-Responsible for preparing PMS report
-Responsible for preparing design file
-Responsible to prepare IVR report
-Responsible to conduct outside testing as per requirement
-Responsible to optimize the process as per requirement
-Responsible for testing of evaluation piece as per requirement
-Responsible for communication with outside laboratory as per requirement
-Responsible for training of employ for rejection control and other GMP training.
**Authority
-Authorized to Check In process and Finished product Quality of any department
-Authorized to raise corrective and preventive action regarding Quality of Product
-Authorized for internal quality audit.
āļāļļāļāļŠāļĄāļāļąāļāļīāļāļđāđāļŠāļĄāļąāļāļĢ - Education (āļāļēāļĢāļĻāļķāļāļĐāļē): Bachelor's degree in engineering or related filed
- Working experience (āļāļĢāļ°āļŠāļāļāļēāļĢāļāđāļāļēāļĢāļāļģāļāļēāļ): Minimum 2 yearsâ experience in quality control position with at least 1 years in the pharm/medical device industry is required.
- Specific skill/knowledge (āļāļąāļāļĐāļ°/āļāļ§āļēāļĄāļĢāļđāđāđāļāļāļēāļ°āļāļēāļ): Must have knowledge ISO 13485 and ISO 9001 requirements. MDR or MDD is advantage
- General knowledge (āļāļ§āļēāļĄāļĢāļđāđāļāļąāđāļ§āđāļ): Fluent in written and spoken English Computer literacy: MS Office required.
- Working day Mon-Sat. (Sat. follow to company calendar) at 08.30 am. - 05.00 pm.
- Can Start work immediately will be advantaged
- Ability to work under pressure and to strict deadlines
- Integrity and a professional approach to work.
- Work Proactive, Fast Learning, Team Motivation, Good Problem Solving and Explore the Possibility
- Can work overtime on normal work days or on weekend
āļ§āļīāļāļĩāļāļēāļĢāļŠāļĄāļąāļāļĢ-āļŠāļĄāļąāļāļĢāļāđāļēāļ JobThai
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