SUMMARY OF ESSENTIAL FUNCTIONS:

Candidate must be flexible and have well-developed organizational skills and have the ability to interact with all levels of personnel. Candidate must be a self-starter, results oriented individual with ability to articulate, receive, disseminate and analyze data. Candidate is responsible for assisting in managing the development, implementation and maintenance of quality assurance standards 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:

• 
  The inspection, sampling and retention of materials and products received;
• Check the identity and quantity of each material issued to production against the Bill Of Materials (BOM);
• Perform routine conduct and reporting of in process checks to ensure operation compliance including line clearance check, daily in process report and reconciliation;
• Check the quality, accuracy and consistency of the labels printed in the print room;
• Report failures or concerns to Production Supervision and Quality Management Team;
• Review of relevant batch documentation of the finished product;
• Work closely with peers on timely completion of deviation investigation and follow further checks, remedial action and required documentation;
• Collect environmental, water, and air samples as required. Communicate with contract laboratory performing analysis. Evaluate and report data;
• Assist in preparing the regulatory authorities, customer audits and self-inspection;
• Develop new procedures, and review and update existing procedures;
• Use and extract information from the following systems: JDE, TrackWise and ComplianceWire;
• Support activities of Quality Manager;
• Supports Quality Management Review;
• Supports Document Management as needed;
• Support validation activities as needed.

POSITION REQUIREMENTS:

Education: Bachelor Degree

Experience: 3 years or above of experience working in a pharmaceutical/device packaging industry with emphasis in the clinical space preferred. Licensed pharmacist preferred.

KNOWLEDGE/SKILLS:

• Good mathematics skills, statistical software or application skills preferred;
• Good written English is required ;
• Understanding of pharmaceutical procedures;
• Candidate must have the ability to work effectively under high pressure with multiple deadlines;
• Candidate must be detailed oriented with good oral and written communication skills and good interpersonal skills;
• Candidate must have computer skills with MS Office and capable of quickly learning other software including Documentum, TrackWise and ComplianceWire.
  

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;
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
• 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 judgment. 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：浦东新区外高桥保税区日樱北路353号10部位