职位详情

  • Sr. Product Quality Assurance 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:

  • Candidate must be flexible 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 implementation and maintenance of quality assurance and in-process control 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 RESPONSIBILITIESINCLUDE BUT ARE NOT LIMITED TO:

Deviation Management

  • Be familiar with deviation handling process, be capable of technical communication with other departments, recommend the effective CAPA plan etc.
  • Acknowledge how to define classification of deviation
  • Follow-up the deviation investigation until its appropriate closure
  • Follow-up the implementation of CAPA. Trend Monitoring and take actions where appropriate.
  • Follow-up the effectiveness check

Complaint Management

  • Acting as local complaint coordinator, ensure timely document and perform impact assessment
  • Acknowledge recurrence query method according to global complaint procedure
  • Monitoring complaint progress and closure
  • Follow-up the implementation of CAPA. Trend Monitoring and take actions where appropriate.
  • Follow-up the effectiveness check

incoming Material Release

  • Review of incoming materials / products receiving and inspection documents, recommend any question or doubt if any
  • System update (e.g., status, expiration date, country)
  • In house material specification review and approval
  • LAF review and approval
  • Double check JDE system sheets in the processing of incoming materials

Finished Goods Release

  • Review and Approve executed batch packaging record, especially for primary packaging record
  • Initiate Certificate of Complaint for each batch record
  • System Update (e.g., status, expiration date, country)
  • Master some special customer batch release process, including system handling, release regulation etc.
  • Double check JDE system sheets in the processing of finished goods.


Other requirements

  • Assist in preparing the regulatory authorities, customer audits and self-inspection.
  • Provide technical input to other functions, regarding technical and quality relevant topic, e.g., investigation SME, Quality Expertise in Material / Production disposition, etc.
  • Manage GMP documentation Issuing, retrieving and archiving.
  • Coordinate training and ensure that the correct curricula are developed in collaboration with departmental management.
  • Lead Annual Mock Recall Activity, coordinate with other departments and client regarding to recall.
  • Support activities of Production QA Supervisor.


POSITION REQUIREMENTS:

  • Education:   BS Degree, Major in Pharmacy, Chemistry, Biochemistry is preferred
  • Experience:  5 years of experience working in a pharmaceutical industry with 2 years QA experience.


Knowledge/Skills:  

  • 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 JDE