Provide compliance guidance and analysis to client, help clients successfully pass the official inspection of target market, assist in maintaining the client's ongoing compliance status. Besides, lead and guide in-house technical teams, support the talent development.

Key responsibilities:

1. Responsible for the GMP compliance consulting projects, covering EU, US, PIC/S, and Chinese regulations.

2. Responsible for new plant design review, layout concepts and basic concepts (e.g. hygienic concepts), technical concept (e.g. qualification and validation concepts).

3. Execution of gap analysis, covering dosage and API compliance analysis.

4. Implement external GMP compliance training, to improve client’s quality management.

5. Support establish and optimize the company knowledge system, internal training.

Qualification:

1. Background in related fields such as pharmacy, pharmaceutical engineering, chemistry and biotechnology.

2. Minimum of 15 years working experience in pharmaceutical industry and 10 years working experience in quality management.

3. With experience of successfully leading domestic and overseas GMP projects and pass the authority inspections.

4. Good spoken and written English language skills, good listening and speaking is preferred.

5. Available for short term business trip.

Provide consulting and project implementation service, as well as manage and maintain projects. QMS Experts focus on assisting client withestablish quality system, review documents and maintain the operational quality, perform compliance audits. Meanwhile, you can participate in the interested projects per your expectation.

Key responsibilities:

1. Organize and implement customer documentation system establishment, manage project’s process.

2. Plan and execute GMP compliance audit, including sterile products, biological products, dosage, API, and others.

3. Assist client’s QMS related activities, and provide compliance consultation, i.e., review deviation,change, batch record.

4. Assist in the preparation, training and maintenance of documents for the internal quality management system.

5. Prepare other GMP related technical documents, i.e., validation and qualification.

6. Provide training service, guide client to comprehend the key points of GMP.

7. Technical support in the project negotiation process.

Qualification:

1. Graduated in related fields such as pharmacy, pharmaceutical engineering, chemistry and biotechnology.

2. Professional knowledge of pharmaceutical quality and production, be familiar with relevant knowledge of overseas and Chinese GMP regulations.

3. Minimum of 5 years experiences in GMP quality system.

4. Good spoken and written skills in both Chinese and English.

Provide consulting and project implementation service, as well as manage and maintain projects. Validation experts focus on providing support and guidance to all qualification and validation relevant projects, covering the new factory construction and project C&Q management, establish Q&V management system, prepare or review facility and utility system qualification documents.

Key responsibility:

1. Prepare and review GMP validation and qualification documents, including plant validation, facility validation, equipment validation and utility system (air conditioning systems, water systems); review the related documents.

2. Review and guide process validation, cleaning validation and/or computerized system validation in pharmaceutical industry (can execute computerized system is preferred).

3. Participate in preparing GMP documents and executing risk assessment.

4. Support and assist other related services e.g., gap analysis for dosage and API plant, design review.

5. Provide technical support during business negotiation.

Qualification:

1. Graduated in related fields such as pharmacy, pharmaceutical engineering, chemistry and biotechnology.

2. Minimum of 5 years working experience in GMP quality field, or production and engineering department.

3. Be familiar with the requirements of validation according to the regulations and guides of FDA, EU, ISPE, ICH etc.

4. Available for short term business trip.

Provide consulting and project implementation service to biological clients, as well as manage and maintain projects.

Key responsibility:

1. Organize and implement customer documentation system establishment, manage project’s process.

2. Plan and execute GMP compliance audit, including biological products, dosage, API, raw material, package, and others.

3. Assist with client’s QMS activities, provide compliance support, e.g., review deviation, change, batch record;

4. Assist in the preparation, training and maintenance of documents for the internal quality management system.

5. Prepare other GMP-related technical documents, i.e. validation and qualification.

6. Provide training service, guide client to comprehend the key points of GMP.

7. Technical support in the project negotiation process.

Qualification:

1. Graduated in related fields such as pharmacy, pharmaceutical engineering, chemistry and biotechnology.

2. Minimum of 5 years experiences in GMP quality field, with two-year or above working experiences in biol products, familiar with biopharmaceutical process and on-site control.

3. Familiar with relevant knowledge of overseas and Chinese GMP regulations.

4. Available for short term business trip.

CSV Specialist assist experts in executing CSV projects smoothly. Here, you will accumulate work and project experience by exposure of various computerize systems, to build a solid foundation for further career development.

CSV Experts provide CSV compliance consulting and implementation service, including CS management establishment, IT validation for ERP/ WMS/ LIMS/ SAP/ DCS, as well as data integrity consultation and related training.

Key responsibility:

1. Establish and improve the CS management system to ensure the compliance.

2. Implement all IT validation projects, including initial validation, revalidation and supplementary validation.

3. Prepare or review CSV plan and protocol; support onsite CSV and prepare the report.

4. Provide compliance consultation and training regarding of CS management, CSV and DI.

5. Participate in CSV related audits.

Qualification:

1. Graduated in related fields such as computer, automation, software engineering, medicine or related field.

2. Minimum of 3 years related working experiences in pharmaceutical quality, engineering or IT department, familiar with basic requirements in GMP environment.

3. Practical experiences in computer system verification, one or more of the following verification experiences is preferred, such as SAP, LIMS, WNS, etc.

4. Familiar with GMP regulations, GAMP5 requirements on computer system verification and electronic data, and able to verify and preserve database safe operation and fault handling, resource optimization with capacity planning according to regulations.

5. Good command of English, especially good at reading and writing English documents, fluency in oral English is preferred.

6. Available to business trip as required.

Assist Experts for executing GMP relevant projects. Here, you will accumulate the working and project experience by participating different projects, which is helpful for consolidating the foundation of career development.

Key responsibility:

1. Collect and update the regulatory requirements related to pharmaceutical and other Life Sciences industries.

2. Support preparating GMP SOPs according to the latest regulatory requirements and actual practices, i.e. Quality Management, Lab Management, Manufacture Management.

3. Assist in translation GMP documentation.

4. Support audit execution, including: sterilization, drug, API, package, etc.

5. Assist in preparing training document and follow up the project procedure, reach client’s requirements.

6.Other duties as assigned.

Qualification:

1. Graduated in related fields such as pharmacy, pharmaceutical engineering, chemistry and biotechnology.

2. Pharmaceutical knowledge in quality or manufacturing of drugs. Familiar with overseas and Chinese GMP regulations is preferred.

3. Minimum of 3 years plant QA experience in pharmaceutical industry.

4. Experiences on quality system establishment is preferred.

5. Good knowhow in English reading and writing.

Individually collect, categorize all GMP relevant regulations and guidelines, keep internal knowledge base up-to-date. Summarize the regulatory updates and provide periodic learning material to intracompany technical teams.

Key responsibilities:

1. Responsible to collect, categorize and update regulation and guideline issued in both China and oversea, covering NMPA, FDA, EMA, EDQM, PIC/S, ISPE, PDA, ICH, GB.

2. Periodically summarize the regulatory updates, prepare the internal learning and training material.

3. Prepare and provide the latest regulatory support to customer.

4. Internally regulatory support for technical team, and regularly share up-to-date regulation and train internal staff.

5. Collaborate on establishing and maintaining company’s knowledge base.

Qualification:

1.Graduated in related fields such as pharmacy, pharmaceutical engineering, chemistry and biotechnology.

2.Good English reading and writing skills; can undertake the domestic and oversea data collecting independently.

3.Team Player with excellent interpersonal skills.