职位详情

  • Sr. Operational Quality Officer
  • 外高桥保税区
  • 面议
  • 2024-06-19 更新
  • 业务事务部Clinical Supply Services

职位属性

  • 职位数1
  • 工作性质全职

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.