品保專員 OQ Specialist (歡迎應屆畢業生加入)

1. Facilitate Lot disposition process, reviewing GMP docs and managing timelines. 

2. Support day-to-day Quality Assurance - Operations. 

3. Perform batch disposition activities within specified timelines. 

4. Ensure timely review of batch records, SOPs, investigations, and adherence to  

quality agreements. 

5. Set meaningful goals, metrics for groups, and manage performance. 

6. Ensure safe, quality, and timely work. 

7. Participate in continuous improvement projects, including QA systems and  

shopfloor processes. 

8. Manage non-conformances investigation and compliance. 

9. Ensure quality production and operation in accordance with schedule. 

10. Quality Assurance management, covering documentation control, batch record  

review, investigations, production support, training, and compliance initiatives.

1. Establish analytical methods of microbial and execute method validation to  

ensure analytical method accuracy. 

2. Issue blank test report for conduct raw material/package material, semi-  

product/product and stability analysis, sampling and records, to ensure product  

quality meets PIC/S GMP requirements. 

3. Review of project plans and analysis result reports, inspection/test reports, and  

SOPs. 

4. Conduct test on water for production, Total organic Carbon of water system in  

laboratory systems and microbial test to ensure the quality of the water. 

5. Conduct preparations of growth mediums and potency and growth tests of  

growth mediums to ensure microbial test run smoothly. 

6. Conduct bacterial sub-culturing ,culturing, identification and counts to ensure  

microbial tests run smoothly. 

7. Conduct environmental monitoring of production zones A,B and C(bacterial test  

on air conditioning system to ensure the conditions of production environment  

meets GMP requirements. 

8. Conduct cleaning and maintenance of all instruments and equipment,  

calibrations/validations and sort yearly assessment reports to maintain normal  

usage of instruments and equipment. 

9. Perform self-inspections or internal audits as required by the audit schedule.

1.開發調整分析方法(HPLC, GC, IC...)，協助產品製程開發，分析方法之確校 

2.執行實驗室設備3Q  

3.研擬審查藥典相關產品規格及分析測試，建立藥典規格 

4.操作化學分析儀器進行分析，協助產品放行

1. Review and enforce adherence to quality standards and agreements. 

2. Manage non-conformance investigations and compliance. 

3. Oversee GMP and regulatory compliance. 

4. GMP Supplier Oversight: 

-Oversight the GMP Vender Audit Schedule. Ensuring Vendor and Auditor availability (internal/external/consultant) and confirming audit dates with both auditors and vendors. 

-reviewing supplier audit reports, ensuring they meet Lotus QA Standards and are compliant with Lotus SOPs. 

-Submitting observation reports to vendors, communicating response timelines and tracking them to ensure timely responses. 

Review of vendor audit responses and managing the review/editing cycle until responses are acceptable. Requesting documented evidence of closure when necessary and filing electronically and hard copy. 

5. Manage quality assurance tasks including document control and investigations.

1.開發調整分析方法(HPLC, GC, IC...)，協助產品製程開發，分析方法之確校 

2.執行實驗室設備3Q  

3.研擬審查藥典相關產品規格及分析測試，建立藥典規格 

4.操作化學分析儀器進行分析，協助產品放行