Principle Roles & Responsibility

• Participate in the work related to new product introduction and organize the drafting of R&D related contracts.
• Perform process transfer, process validation and cleaning validation of new products, draft process documents (process flow documents and master batch record, etc.) prior to product commercialization.
• Participate in product-related design work, including but not limited to: new equipment design, tablet/capsule appearance design, printed packaging material design, inner packaging layout design, etc..
• Cooperate with the preparation of relevant documents for product registration.
• Review the validation documents related to the process and cleaning such as revalidation, continued process verification, etc. after commercialization of the product; review the process documents of commercialized products.
• Cooperate with deviation investigation and change impact assessment in the production process.
• Cooperate with the work related to the declaration of high-tech enterprises. Apply for R&D related government subsidies.
• Other R&D related matters.

Qualification and Experience

• Bachelor degree or above, pharmacy related majors.
• At least five years working experience in oral solid dosage.
• Familiar with the technical transfer, process validation and cleaning verification/validation.

If interested, please forward your resume to yuhuaw@hutch-med.com

Primary

• Responsible for Chemical test in QC laboratory

Principle Roles & Responsibility

• Strictly follow the relevant standard operating procedures and testing method procedure of laboratory;
• Execute the release testing of raw materials, packaging material, intermediate products and finished products, and initiate the relevant testing reports.
• Execute the finished product stability testing, and initial the relevant stability reports.
• Initial and revise the chemical test methods and specifications for all materials (including raw materials, excipients and packaging material), intermediate products and finished products;
• Initial and revise the protocol of method transfer and validation for chemical testings;
• Execute method transfer and validation according to protocol, initial and review the validation report accordingly;
• Initial and revise the standard operating procedures for relevant equipment, instruments, reagents, test solution, reference standards and volumetric solutions;
• Initial and revise the validation protocol for laboratory chemical analysis instruments; cooperate in the qualification/validation, maintenance and calibration of instruments used for chemical testing.
• Responsible for the chemical testing for utility qualification, key production equipment qualification, product process validation and cleaning validation;
• Report the OOS results, and conduct laboratory investigation per line manager instruction;
• Provide specific information when communicating with government drug testing agencies;
• Responsible for the safety, health and environmental protection (EHS) of itself position;
• Complete other tasks assigned by line manager.

Qualification and Experience

• College degree or above in pharmacy relevant major;
• 2 years of relevant work experience;
• With good physical and chemical testing skills and knowledge;
• Familiar with chemical laboratory procedures， laboratory instrument operation and regulatory requirements;
• Experience with chemical method validation is preferred;
• Experience with USP and EP is preferred.

If interested, please forward your resume to Yuhuaw@hutch-med.com

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