Overview
Operational Quality Officer Jobs in Shanghai, Shanghai, China at 广东弘景光电科技股份有限公司
Title: Operational Quality Officer
Company: 广东弘景光电科技股份有限公司
Location: Shanghai, Shanghai, China
该职位来源于猎聘 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 inspection and release, in house labelling printing activities etc. perform functional role to following current GxP requirement. Skilled in using GSA, CT WIN and iDS system in quality part and perform Catalent environment monitoring. SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: 61 Independently responsible for the following modules and able to solve problems in daily work:
- Implement in-coming material inspection and quality oversight.
- Final determination of Material defect and review of Defect Notification Form.
- 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.
- 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 behalf 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. 61 Familiar with TrackWise system, be able to complete change control, investigation/deviation, and action as owner. Provide technical input to above case. 61 Deviation Management
- Fundamentally acknowledge deviation handling process, perform preliminary impact assessment
- 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 61 Assists with regulatory and customer audits of the facility as required. 61 Train and coach operational quality personnel to perform their assignment properly. 61 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.
