職位描述
To assist the RC/QMS Section Manager in ensuring site regulatory compliance to GSK & regulatory standards.
To ensure registration documents for products are submitted correctly.
To ensure internal audit system, QMS system effectively.
Support to prepare and host L4 inspections.
To ensure package standard sample checking is effective and accurate.
Work with Procurement Share Service group and Supplier Quality Share Service group to ensure effective supplier quality management in GSKT site.
Establish and maintain document control, archive and security system, BOM and API system, SOP training matrix system.
To be TC of mylearning system of compliance training.
Check and control the document system according to GMP.
Key Responsibilities主要崗位職責(zé):
1. General responsibilities:
? Be responsible for the preparing, reviewing, and updating of SOPs related.
? Perform QMS gap analysis for relevant policies and training.
? 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
? Trouble shooting in RC/QMS area
? Perform other jobs assigned by RC/QMS Section Manager.
2. 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.
? Conduct training related to regulations for relevant departments accordingly.
? Maintain Site Master Fill System and timely updated according to relevant change.
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.
Recall
? Maintain site recall SOP through QMS gap analysis。
? Communicate with regulatory authority during recall
? Archive the meeting minutes and maintain LIC and PIRC list
Internal and External audit
? Maintain internal auditing system, prepare annual L2 audit schedule and coordinate each L2 audit.
? Maintain L1 inspection system, follow up L1 inspection adherence with each department.
? Familiar with L1 inspection process, conduct L1 inspection in RC/QMS Section.
? Conduct L2 inspection on schedule.
? Ensure all CAPA arising from internal audit is tracked effectively.
? Maintain CARISMA3 data, enter L4 report, enter findings, CAPAs of L3 and L4 audits, and follow-up and close in a timely manner.
? Prepare and maintain GMP orientation training material, annual GMP training material. Deliver GMP orientation training to new staff.
? Support on L3 and L4 audits.
Change Control
? Lead Change Control meeting and maintain Change Control system
Package material compliance
? Prepare packaging components test methods, specifications/STD.
? Review artwork, standard samples.
? Maintain effective specification system, maintain relevant database, make sure both hardcopy, e-version establish, distribution, archiving, retrieve, destroy fully comply with SOP, QMS and GMP requirements.
Supplier management
? Lead the process of Supplier Qualification in the site, working with SQ and PP to achieve this.
? 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.
? Maintain the supplier quality KPIs and drive the improvement.
? Conduct supplier performance review using material complaint analysis.
? Support PP for supplier performance review.
Document Control
? GSKT all products related manufacturing, packaging BOM, item number, API system control, upgrade and maintain, BPCS system maintain according to approved BOM, item number, API hard copies.
? Establish and implement document control system to ensure quality standard, SOPs, batch records, specification, and registration document in place.
? Establish the clear document archive system, Manage Quality file centers, to make sure easily document retrieval.
? Maintain the SOP system, make sure that SOP can be updated and reviewed timely, no outdated quality related documents in use.
? Responsible for site information security system, lead the coordinators of each department to implement information control according to the requirement.
? Responsible for document master list update and maintenan
