** ¿Ü±¹°èÁ¦¾à»ç QA Manager
Provide leadership and management to the Operation Quality Team at *** so as to achieveGMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance.
Continuously evaluate *** quality assurance and control systems, and make quality andoperational improvements as needed through the *** management and change controlsystems, so as to comply with all requirements to satisfy the regulatory requirements in the markets inwhich *** operate, including MFDS and PIC/s standards, and as requested byLotus(***) Group.
Approve Standard Operating Procedures (SOPs), batch instructions, testing instructions, and records,and other necessary GMP and GLP documents, for activities related to *** GJ plantoperations, and support Lotus QMS document.
[Roles & Responsibilities]
Maintain GMP compliance- Keep abreast of the requirements and the latest trends in GMP and attend suitable training to meet those needs.- Provide training to staff on-site on GMP and GLP and monitor people¡¯s training plans for GMP and GLP compliance, if necessary.- Preparation of programs for corrective and preventative actions (CAPA) from any Non-conformities. (Observations, Deviations, OOS, Complaints, etc)2. Quality management activities- Respond to *** queries about the state of quality in ***, and contracted organizations, and suppliers.- Review the Quality technical agreements with 3rd parties required, and work with *** Corporate Quality as needed. (B2B products)- Conduct supplier audit for API and product supplier as an auditor. (Not mandatory)- Follow up on any Corrective actions from audit/inspection and ensure they are closed out.- Approve of the GMP document especially SOP, the master formula for each product- Review/Approval of deviation(OOS)/change control/CAPA/Complaints investigation and completion report.- Review/Approval of quality risk management document.- Review/Approval of qualification/validation protocol and report.3. Operation support- Provide quality support to manufacturing.- Assist with new product introduction and technology transfer, and supporting registrations.- To provide wide-ranging support to the Lotus(***) Quality Team and other personnel in Quality and Operations as needed.4. Organization & Team management- Promote a positive approach to quality throughout the organization.- Reporting on the effectiveness of the Quality Management System. File the agreed Key Performance Metrics monthly as required to Lotus(***) Quality management and monitor performance and help identify improvement and effectiveness activities.- Management of staff, including objective setting for staff, and regular reviews of staff performance in line with *****.- Work closely with the Lotus(*****) Quality and Operations and Compliance Teams worldwide as required.- Lead/Support the ***** organization through any required regulatory, customer, and external audits.- Any other quality management activity that is reasonably requested by management.
[Qualfiations]
Pharmacist Lisence
2Professional experience – preferably 10 years, but not less than 5 years, of uninterrupted workexperience in the production and/or control of pharmaceuticals.
To be well acquainted with the MFDS standards, and preferably also European standards on GoodManufacturing Practice (EU-GMP) and Good Laboratory Practice (GLP), as well as other internationalGMP standards.
Good computer skills.
Good command of Korean and English
49 years±îÁö °ËÅä.
** À̸ÞÀÏ
- sgchung2002@hanmail.net(¿µ¹®CV)
- ÇÁ·ÎÇÚÁîÄÚ¸®¾Æ Á¤¼ö±æºÎ»çÀå 010-6566-6370
- ASAP
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003