SUMMARY OF ESSENTIAL FUNCTIONS:

Candidate must be flexible have the ability to interact with all levels of personnel and own certain organizational skills. Candidate must be a self-starter, results oriented individual with ability to articulate, receive, disseminate and analyze data. Candidate is responsible for implementation and maintenance of quality assurance and procedures as well as quality systems to ensure the precision, accuracy and reliability of company products in accordance with quality specifications, government, company and GMP standards.

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Establish, write and update procedures where appropriate

• Perform goods receiving document / batch record review and material & product release

• Ensure all suppliers used directly by Catalent Shanghai are evaluated for compliance with Catalent and regulatory requirements and maintain an annual audit schedule for Suppliers.

• Ensure Risk Management approaches for the assessment, control, communication and review of risks to the quality of the products are used in Process design, Deviation, Change Control, Qualification and Validation, etc. all product quality related site activities.

• Coordinate the audit from regulatory authorities, customer, corporate and self-inspection.

• To ensure that deviations/complaint/change control are communicated, managed, reported, tracked and trended and that CAPAs are effective.

• Coordinate the Supplier Audit Program, performs off-site audits and audits via questionnaire.

• Coordinate the validation program to ensure the facility, equipment that may impact GMP activity are validated and calibrated.

• Support Training and Documents archiving program if needed.

• Support activities of Quality Assurance Manager.

POSITION REQUIREMENTS:

Education: Bachelor or above in a Science or Pharmaceutical discipline

Experience: 5 years of experience working about quality.

Knowledge/Skills:

• Must be fluent in both English and Mandarin. Reading and Writing in both languages is required.

• Full understanding of cGMP regulations pertaining to clinical packaging in regulatory territories such as FDA, EU and PMDA.

• Knowledge of Quality Assurance and Regulatory Affairs matters as applicable to the pharmaceutical industry.

• Good understanding of pharmaceutical procedures and core technologies such as manufacturing and packaging.

• Candidate must have the ability to work effectively under high pressure with multiple deadlines.

• Candidate must have computer skills with MS Office and capable of quickly learning other software including JDE,Trackwise,Compliancewire

• Must be a creative and analytical thinker with sound business judgment and good negotiation and reasoning skills.

PHYSICAL/MENTAL REQUIREMENTS：

• Mathematical and reasoning ability

• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

• Ability to work effectively under extreme pressure to meet deadlines. Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

• Overall about average intelligence, creative thinker with sound business judgement. Good negotiation and reasoning skills.

• Excellent written and verbal communications skills. Ability to easily learn and retain technical information. Must be fluent in both Chinese Mandarin and English.

• Excellent problem-solving skills, including innovative and creative solutions.

• Well organized with ability to handle multiple activities simultaneously.

• Self-starter with the ability to work with people at all levels within Catalent and within customer organizations.

上班地址：外高桥保税区