Key Responsibilities:
?Be responsible for the preparing, reviewing, and updating of SOPs related.
?Perform QMS gap analysis for relevant policies and deployment the QMS requirements in site.
?Trouble shooting in RC/QMS area.
?To assist RC Section Manger to notify authorizes of regulatory related issue.
?Maintain China QP system to comply with China regulation.
?Assist Head of Quality to organize Quality council.
?Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures.
?Internal & External Audit related
?Supplier management
?Perform other jobs assigned by RC Section Manager.
Specific responsibilities:
Regulatory Compliance
?Prepare product registration dossier and samples.
?Support NPI team to prepare new product introduction required submission dossier.
?Prepare application document for changing manufacturing certificate for new product ａｄｄition.
?Maintain new/ｕｐｄａｔｅd regulation follow up process and ensure the appropriate gap analysis is conducted.
?Archiving and maintaining registration dossier related to the site.
?Conjunction with GMS Regulatory Affairs Department to establish the China regulations information database in ensuring site regulatory compliance to China regulatory standards.
?Maintain site quality regulatory intelligence to generate initial assessment, identify risk and response timely.
?Generate initial regulatory advice to support other function and conduct training related to regulations for relevant departments accordingly.
?Maintain Site ｍａｓｔｅｒ File System and timely ｕｐｄａｔｅd according to relevant change.
?Support PPR for RC related activities.
?Lead the process of customer complaint investigation and ensure customer complaint report complete timely.
Supplier management
?Lead the process of Supplier Qualification in the site, working with SQ and PP to achieve supplier profile timely.
?Supplier change management. Follow site change control process to get the change initiated, follow up and close. Working with SQ and PP to get necessary support.
?Communicates with suppliers ensuring they understand site quality requirements.
?Lead the process of supplier complaint investigation and ensure supplier complaint report complete timely.
QMS
?Support to maintain QMS implementation system at GSKT, circulate QMS release information and track gap analysis.
?Ensure all CAPA arising from QMS gap analysis is tracked effectively.
?Prepare and maintain GMP orientation training material, annual GMP training material. ｄｅｌiver GMP orientation training to new staff.
Product Incident and Recall
?To assist RC Section Manager to maintain product incident SOP through QMS gap analysis.
?Archive the meeting minutes and maintain LIC and PIRC list.
Internal audit
?Maintain internal auditing system, prepare annual IBM inspection schedule, and coordinate each IBM audit.
?Maintain MM inspection system, lead every department to complete MM inspection schedule, and follow up MM inspection adherence with each department.
?Familiar with MM inspection process, conduct MM inspection in RC Section.
?Follow up IBM inspection on schedule.
?Ensure all CAPA arising from internal audit is tracked effectively.
?Support RC section manager to prepare GSK global audit, and set up inspection readiness plan, follow up CAPA closure.
External audit
?To assist RC Section Manager to prepare for external audit, set up inspection readiness plan.
?Maintain VQMS data, enter Regulatory Inspection report, enter findings, CAPAs of A&A and Regulatory Inspection audits, and follow-up and close in a timely manner.

Change Control
?Lead Change Control panel meeting and maintain Change Control system as system owner.
?Support management team review Change Control KPI and lead the change control system improvement in GSKT site.
?Support on change risk management
KPI and Quality Risk Moｄｅｌ
?Support site leadership to generate data for quality risk moｄｅｌ and follow up.
?Support management team review quality KPI and follow up the system improvement in site.
Education Background:
?Bachelor’s degree and above in physical science, Pharmacy, Biology, Chemistry or related field
?Fluent in written and spoken English.
Professional Experience：
?Minimum 3 years of experience in quality/GMP field, at least 1 years in related quality compliance area

上班地址：-天津-第五大街 開發區二小對面