Senior TPCQ Specialist should be familiar with Drug and Medical device product China GSP and GMP requirements, he/she will be responsible for China QMS maintenance and periodic quality data review including complaint, deviation, transit temperature assessment data, Medical device AE reporting, Training implement, post-marked regulation monitoring and import Drug test result. The role can analyze the quality data trend and report the potential quality risk to the upper manager. The role can communicate to resolve the problem with cross function team, such as local venders, China test institution and reginal/plant QA.
Supporting product release in China, including:
• Drug COA translation
• Reference standard and HPLC supply
• Submit updated drug specification to government test agency
• Maintain the test report. Make trend analysis for Botox potency to identify any signals. Sharing the trend information to plant QA on time
China QMS Maintenance to ensure China QMS meet Allergan Corporate/Reginal quality and China regulation requirements
• Prepare Technical/Quality Agreement with local distributors
• Prepare the input of Management review
• Post-marked regulation changes periodic review. Create change control in GTW and perform the gap analysis when necessary.
• Draft monthly quality report for QA head review.
• Improve China SOP to meet the new global quality requirements and new regulation requirements
• Maintain Audit related records in GTW, including regulatory audit, internal audit. Create and close the observations and responses in GTW.
• Supporting global quality audit for local distributors/suppliers, including submit the audit request form.
• Managing the site records for local suppliers in China in GTW, maintaining quality agreement, licenses, certifications.
Be coordinator for the change control raised by local team:
• Initiate the change control raised by local team, such as new products launch in China, product discontinuation, local distributor change, etc.
• Coordinate with cross function to align the change action plan and impact and risk assessment.
• Create and maintain the change control record and change actions in GTW, and make sure the record closed on time.
Be coordinator for NC/CAPA raised by Local team:
• Report the NC/CAPA in GTW timely.
• Ensuring the NC/CAPA follow internal process.
Be back up :
• Non-medical complaints
• Shipment temperature assessment
• Relabeling batch record review
• E-code operation.
Other tasks required by China QA head.
• Bachelor’s degree or above, major in Pharmaceutical
• At least 5 years QA working experience in Pharmaceutical or Medical device industrial.
• This role should have strategic thinking and insight, he/she can deliver some strategic ideas to support QA team and business development
• Have QC laboratory work experience and familiar with China GMP regulation related with Drug products in China, and have rich quality management experience in foreign pharmaceutical company
• Strong problem solving and communication skill, can be good at the risk assessment tools to seek the solution for complicated problems