- Responsible for maintaining, auditing, and implementing facility Quality Assurance and ISO programs to meet or exceed all applicable regulatory and customer requirements in accordance with the goals and objectives of Corporate Quality Assurance.
DUTIES AND RESPONSIBILITIES:
- Review and release of production runs in E1.
- Perform the process history record review and approval which consists of the following:
- Generate certificates of irradiation from E1
- Certification of Dose Distribution
- Verify that all paperwork/ documentation is present and properly completed
- Maintain and update Customer Master Files. Review and approve all customer master file listing entries/changes.
- Calibrate and validate measurement equipments, review and document calibration and maintenance records.
- Audit and approve suppliers.
- Investigate and document customer complaints, including manage customer complaint file.
- Investigate and document Notices of Nonconformance and Deviations.
- Lead customer and regulatory audits.
- Respond to and assist in customer, Corporate and regulatory audits.
- Assist in troubleshooting problem areas.
- Establish and maintain facility procedures manual(s).
- Provide technical information to customers, other managers upon request.
- With ISO, assure compliance with the Radioactive Material License and its contents - assist in loadings and re-commissioning process.
- Analyze data for continuous improvement activities.
- Assist General Manager and Corporate QA in special projects as needed.
- Ensure facility compliance to the documented quality system.
- Ensure facility management up to ISO 9001 standard and ISO 13485 Medical devices (Quality management systems).
2. Administration/ Training/ Others
- Prepare training documents and conduct training sessions on: GMP's and company's Procedures.
- Maintain training records.
- Maintain audit records.
- Ensure Thai translation documents were translated by Translation Center correctly. Revise Thai version documents according to English version changes.
- Issue controlled documents to various working areas, as needed.
- Participate in Environmental Management System Team. Responsible as a Document Controller (DCC), and Internal Auditor.
- Bachelor's Degree in related field or equivalent and Master's degree is plus.
- Minimum 2 years experience in Quality Assurance Manager from the medical device/ health care industry is preferred.
- Well knowledge of ISO 9001 standard and ISO 13485 Medical devices (Quality management systems).
- Computer literate with ability to use Microsoft Word, Excel, and Power Point.
- Very good command of Thai and English both written and spoken.
- Interpersonal skills and experience with international company/ever to work with corporate.
Interested candidates please send your update resume, current and expected salary with contact details to:
ManpowerGroup Thailand - Eastern Seaboard Branch
143/165 Moo 12, T.Nong-prue, A.Banglamung Chonburi 20150
Contact Khun Jaru Sritin (Professional and Executive Consultant)
Telephone no. 033-135014 ext.3405 or 089-2739854