QA Manager

หน้าที่และความรับผิดชอบ

• Responsible for maintaining, auditing, and implementing facility Quality Assurance and RSO programs to meet or exceed all applicable regulatory and customer requirements in accordance with the goals and objectives of Corporate Quality Assurance. 1. QA/Regulatory • Review and release of production runs in E1 • Perform the process history record review and approval. • 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 RSO, 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, ISO13485 and ISO14001 2. Pharmaceutical Project • Prepare training documents and conduct training sessions on GMP’s, Corporate’s Procedures • For GMP authorized Person • Head of Quality Assurance, generally have some shared, or jointly exercised, responsibilities relating to quality including the design, effective implementation, monitoring and maintenance of the Pharmaceutical Quality System. These may include, subject to any national regulations 3. Administration/ Training/ Others • Maintain training records • Maintain audit records • Ensure Thai translation documents were translated by the Translation Center correctly. Revise Thai version documents according to English version changes. • Issue controlled documents to various working areas, as needed. • Participate in the Environmental Management System Team. Responsible as a Document Controller (DCC), and Internal Auditor.

คุณสมบัติ

คุณสมบัติด้านความรู้และความสามารถ

• • Male or Female • Age can be 35 + years old • Minimum Bachelor of Science in Biology or related field or equivalent, MS, MBA is a plus • Minimum 5 years’ experience in Quality Assurance and/or the medical device industry. • Fluent in English • Must complete training as specified in Document (TRAIN-GA-005) • Computer literate with ability to use Microsoft Word, Excel, PowerPoint and Oracle

สวัสดิการ

• ประกันสังคม
• ทำงานสัปดาห์ละ 5 วัน
• ประกันชีวิต
• ตามข้อตกลงของบริษัท
• สิทธิการเบิกค่าทันตกรรม

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