Please send your application to Recruiter.China@catalent.com.

SUMMARY OF ESSENTIAL FUNCTIONS:

• Provide quality control in place and implement quality oversight for all the operational activities in Catalent operation area, including but not limited to material in-coming, production and pre-production activities, in house labelling printing activities etc.
• perform functional role to following current GxP requirement.
• Skilled in using Supply Flex, GSA, CT WIN and iDS system in quality part and perform Catalent environment monitoring.

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIESINCLUDE BUT ARE NOT LIMITED TO:

• Independently responsible for the following modules and able to solve problems in daily work:
• Implement in-coming material inspection and quality oversight.
• Implement in process control for products relevant activities (sampling, inspection, in-process test etc) and ensure the implementation.
• Drives process efficiencies in inspection of incoming materials and products received in-process quality inspections during packaging jobs and initial review of executable packaging batch records.
• Implement in house Label Printing inspection and release.
• Handle on retain sample activities and ensure implementation.
• perform overall monitoring for GxP Environment, e.g., PW monitoring, Environment Monitoring, etc. Provide data to insight and trend analysis per procedure and GxP best practice.
• Manage and oversight the external activities that on behaviors of Catalent Operational Quality, e.g. sampling, environment monitoring activities, and etc.
• Implement the reliability, fit for use and GxP compliance for the sampling area.
• Perform physical inspection and reconciliation on Materials recalled or to be destructed if required.
• Familiar with TrackWise system, be able to complete change control, investigation/deviation, and action as owner. Provide technical input to above case.
• Participate in qualification/validation relevant activity.
• Assists with regulatory and customer audits of the facility as required
• Train and coach operational quality personnel to perform their assignment properly.
• Other duties as assigned.

POSITION REQUIREMENTS:

• Education:  BS Degree in a Science or Pharmaceutical discipline
• Major in Pharmacy, Chemistry, Biochemistry, and equivalent is preferred
• Experience:Five years of experience working in a pharmaceutical industry with at least two years’ experience in Quality function areas with progressive responsibilities.

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.