Professional：

1. Associate degree or above in pharmacy, traditional Chinese pharmacy, chemical analysis, microbiology, or related fields; at least 3 years of experience in a QC laboratory.

2. Familiar with GMP regulations and data integrity requirements for testing; proficient in using precision analytical instruments such as HPLC and GC; able to independently perform physicochemical or microbiological testing.

Work Location: Taizhou Medical City

Submission Email: bin.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Responsible for testing of raw materials, excipients, and packaging materials used in pilot-scale and process validation batches.

2. Be responsible for the inspection work related to technology transfer.

3. Be responsible for the inspection of finished products and related intermediates in the process validation batch.

4. Be responsible for the inspection related to the stability assessment of the process validation batch.

Professional：

1. Bachelor's degree or above in pharmacy, chemistry, mechanical engineering, or related fields.

2. Able to read relevant professional literature, draft or translate relevant English documents.

3. At least 5 years of validation experience in a pharmaceutical factory, familiar with qualification of facility, utilities and equipment (solid dosage forms), computerized system validation, cleaning/instrument validation requirements.

Work Location: Taizhou Medical City

Submission Email: bin.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Responsible for completing project qualification and validation activities, establishing and improving validation protocols, managing and coordinating various departments to execute on‑site validation work.

2. Establish and maintain the validation system, draft the validation master plan and site validation master plan to meet cGMP requirements.

3. Draft and review the validation master plan; review validation documents and records.

4. Perform qualification and validation of equipment, facilities, and analytical instruments.

5. Manage computerized system validation and cleaning validation.

6. Write validation/qualification protocols, risk assessments, and reports, including DQ/IQ/OQ/PQ.

7. Assess and manage validation‑related deviations and change controls.

8. Maintain and manage access permissions for equipment and facilities.

9. Manage periodic reviews and re‑qualification of equipment, facilities, and instruments.

Professional：

1. Bachelor's degree or above in pharmacy, chemistry, or related fields.

2. At least 1 year of QA experience in a pharmaceutical factory, familiar with GMP requirements.

3. At least 3 years of QC work experience, familiar with chromatography systems, QC instruments, etc.

4. Able to read relevant professional documents, draft or translate relevant English documents.

5. Good communication and coordination skills.

6. Strong sense of responsibility, rigorous and efficient work attitude, teamwork and communication skills.

Work Location: Taizhou Medical City

Submission Email: bin.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Assist the quality head in maintaining and building the GMP system of the plant, including updating and reviewing relevant SOPs and quality manuals to ensure compliance with GMP requirements.

2. Be familiar with relevant drug laws and regulations, track regulatory updates, and require internal SOP updates to maintain GMP compliance.

3. Responsible for change control and impact assessment associated with analytical and testing processes, deviation investigation management, and CAPA tracking.

4. Assist in project management, including technology transfer, CDMO oversight, batch record review, product release review, etc.

5. Communicate with department superiors in a timely manner when issues are identified, especially those affecting production, product quality, and compliance. Ensure deviation investigations are resolved thoroughly, completely, and in a timely manner.

6. Review of QC routine testing data, including audit trail review of electronic data; investigation and review of OOS/OOT/OOE results.

7. Apply scientific knowledge to analyze and solve problems.