[KOREA] QAQC Assistant Manager (1-Year-Contract) at Santen

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

11 Apr, 26

Salary

0.0

Posted On

11 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Quality Control, GMP, Quality Management System, Regulatory Compliance, Project Management, Auditing, Risk Assessment, Change Control, KPI Monitoring, SOP Updates, Training, Deviation Management, CAPA, Cold Chain Management, Supplier Audits

Industry

Pharmaceutical Manufacturing

Description

Company Description Santen is a specialized company with a proud 130-year heritage focused exclusively on eye health. As a Japan-originated, global company with our footprint in over 60 countries and regions, our mission is to provide essential and significant value to patients and society through our products and services created from our expertise in ophthalmology and from the patient’s perspective. Job Description Manage/ perform quality operation/activities for Santen Korea to ensure its compliance with applicable local regulatory and Santen requirements for importation, local testing, repackaging, storage and distribution of Santen products. Provide support to maintain a fit for purpose local QMS as per applicable local regulatory authority and Santen’s global requirements to support country quality operation/activities. Perform quality activities and manage quality issues for Santen Korea/ CMO to support the continuous supply of Santen products in compliance to applicable local regulatory authority and Santen’s global/release requirements. Quality activities include performing maintenance of quality agreement, change control, KPI monitoring, quality complaints management, PMF update, SOP updates and periodic review of QA SOPs, training, self-inspection and audits, deviation/CAPA, risk assessment, preparing Annual Product Quality Review etc. Responsible for management of the contracted laboratories and ensure that method transfers are completed and compliant to applicable established and registered product specifications and requirements. Provide support to ensure all relevant quality input/support to business projects, new product introduction, product launches (including Analytical Method Transfer and DTP creation) and product variation are provided timely. Support management and execution of external/internal audit program for Santen Korea as per applicable local regulatory and Santen global requirements. Participate in ad-hoc activities as requested. Qualifications Successful completion of relevant tertiary qualification – Science degree. (Registered Pharmacist is a plus). At least 3-5 years QA/QC experience in Pharmaceutical and/or Medical Device Company in quality function preferably with 3-5 years in GMP manufacturing plant environment and/or with 3-5 years in Commercial Quality environment. Knowledge and experience in development, implementation and maintenance of a Quality Management System compliant to local regulatory requirements on Good Storage Practice (GSP)/Good Distribution Practice (GDP) and MMC corporate standards is preferred. Good experience in quality monitoring and management of CMO/Distributor/contract laboratory. Direct knowledge and experience in working with GMP and quality management system elements and guidelines (e.g. PIC/S, ICH, ISO9001 or ISO 13485) and cold chain product repackaging. Experience in supporting supplier audits, internal audits, regulatory authority inspections. Ability to manage complex projects and timelines in a matrix team environment Additional Information Grow your career at Santen A career at Santen is an opportunity to make a difference. We aspire to contribute to the realization of “Happiness with Vision” by providing eye health products and services to patients, consumers, and medical professionals around the world. Guided by our CORE PRINCIPLE, “Tenki ni sanyo suru”, Santen is engaged in the global research & development, manufacturing, and sales and marketing of pharmaceutical products in ophthalmology. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment. The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law. If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know. *Please note that team assignments may be subject to future changes

Responsibilities

Manage quality operations for Santen Korea to ensure compliance with local regulatory and Santen requirements. Perform quality activities, manage quality issues, and support business projects related to product quality.