Job Responsibilities:

1. Responsible for identifying and controlling environmental factors and hazards during product inspection and testing processes;

2. Carry out daily recording, cleaning, maintenance, calibration and servicing of laboratory facilities and equipment;

3. Manage the registration and record-keeping of laboratory reagents, test chemicals, culture media and reference standards;

4. Maintain daily records of temperature and humidity in the laboratory and its associated equipment;

5. Prepare, label and record solutions in accordance with statutory standards, industry standards or internal company SOPs;

6. Inspect or re-inspect raw materials, chemical intermediates or finished products in accordance with relevant national standards and technical documents, complete original test records and issue inspection reports;

7. Establish laboratory records and manage their classification and archiving;

8. Assist the Quality Department in analysing and investigating relevant test items in non-conforming products;

9. Draft, revise and supplement various inspection operating procedures in a timely manner in accordance with the actual circumstances of the company’s development;

10. Strictly adhere to internal operating procedures and carry out daily cleaning and maintenance of the laboratory premises.

Job Responsibilities:

1. Responsible for establishing and maintaining the GMP quality system, including the drafting/revision, review, approval and implementation, training, review, and distribution, recall, withdrawal, archiving and destruction of documents;

2. Responsible for the duplication/printing, distribution, recall, review and archiving of blank records, as well as the daily verification of electronic R&D logbooks;

3. Responsible for comprehensive quality monitoring of materials, personnel, hygiene, the environment, equipment and operations on-site, and for compiling inspection findings to be addressed by relevant departments, whilst tracking the rectification of non-conformities;

4. Responsible for the day-to-day management of quality assurance elements such as change control, non-conformities, CAPA, OOS/OOT, quality risks and self-inspections;

5. Responsible for drafting and reviewing protocols and reports for process validation, cleaning validation and equipment qualification;

6. Responsible for the collation, review and archiving of batch records, as well as participating in the review and release of materials and products and supervising product dispatch;

7. Responsible for organising and implementing self-inspections, external inspections and external audits;

8. Responsible for the annual product quality review report;

9. Responsible for the day-to-day management of training for personnel in relevant GMP departments;

10. Other tasks assigned by management. 

Job Responsibilities:

1. Responsible for testing the company’s products under development and analysing the data;

2. Responsible for developing analytical method protocols, conducting experiments and preparing research reports;

3. Responsible for the validation of newly established (or optimised) analytical methods;

4. Responsible for the formulation of quality standards;

5. Carry out other tasks assigned by superiors.

Job Requirements:

1. Bachelor’s degree or above in Medicinal Chemistry, Analytical Chemistry, Pharmacy or related disciplines;

2. At least 3 years’ experience in quality research; familiarity with conventional analytical methods such as ChP, USP and EP, as well as general guidelines such as ICH; solid theoretical knowledge of chemistry and analytical chemistry;

3. Strong problem-solving skills, with the ability to swiftly address anomalies during method validation and routine testing;

4. Proficient in the use of standard instruments such as HPLC, LC-MS and GC, capable of performing annual instrument qualification and maintenance, and proficient in microbiological testing.