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

• Ensure the QC team is adequately staffed to meet product delivery requirements.

• Ensure Quality Control personnel are properly trained to perform their assignment

• The origination of Quality Control procedures (sampling, inspection, in-process control etc.)

• Drives process efficiencies in inspection of incoming materials and products received, in-process quality inspections during packaging jobs and initial review of executed packaging batch records

• Approve Label Printing Request, Inspect and release printed labels and witness destruction of waste labels in label printing process.

• Perform periodical review on retain sample according to SOP requirements.

• Perform Quality Control trending for QMR, Such as PW monitoring, Environment Monitoring, etc.

• Perform physical inspection and reconciliation on Materials recalled or to be destructed if required

• Leads and directs investigations for QC Deviation, follow up the completion of corrective actions assigned to QC

• Participate in the investigation of material/product receiving and packaging related deviations/complaint

• Lead and handle QC Change Control per Change Control Procedure and follow up the change task completion

• Maintain the sampling area cleanness, maintenance, calibration and validation status

• Participate in qualification/validation related with QC

• Support contract lab Supplier Audit Program, performs on-site audits and audits via questionnaire.

• Support in the Internal Audit program

• Assists with regulatory and customer audits of the facility as required

• Support Audit CAPA planning and implementation as SME of Quality Control

• Support activities of Quality Control Manager.

• Other duties as assigned.

POSITION REQUIREMENTS:

Education: BS Degree in a Science or Pharmaceutical discipline

Experience: Five years of experience working in a pharmaceutical industry with at least two years’ experience in QC/QA/RA areas with progressive responsibilities. Experience in managing people and providing leadership.

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 SFDA.

• 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.

• Read and understand MSDS requirements and restrictions.

• Understand Catalent procedures related to document control, Quality Assurance and this job function.

• Previous auditing experience is preferred.

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

• Must be detailed oriented with good oral and written communication skills and good interpersonal skills.

• Must have computer skills with MS Office and capable of quickly learning other software including TrackWise and ComplianceWire.

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

Supervises: Quality Control encompassing Batch review and release, Incoming testing and release of materials.

• 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 judgement. Good negotiation and reasoning skills.

• Excellent written and verbal communications skills. Ability to easily learn and retain technical information.

• 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 Cardinal and within customer organizations.

上班地址：外高桥保税区