- 계약 회사 설명 Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world. 직무 설명
- 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.
- Develop, implement, and maintain a fit for purpose local QMS as per applicable local regulatory authority and Santen's global requirements to support country quality operation/activities.
- Provide support for the development, implementation, and maintenance of a fit for purpose Regional QMS as applicable to support Santen Asia region and/or country quality operation/activities.
- Responsible for quality oversight of relevant local Contract Manufacturing Operation (CMO)/Supplier/ Distributor to ensure the relevant CMO/Supplier/Distributor activities are compliant as per applicable regulatory and Santen global requirements. Provide support to ensure Santen products produced by the relevant CMO is compliant to applicable established and registered product specifications and requirements.
- 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 for the management of chemical reagents, HPLC columns, and reference standards to ensure its continuous supply for local imported product testing.
- 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.
- Manage/Lead all relevant regulatory inspections or certification audits for Santen Korea to ensure successful maintenance / renewal of license and certification.
- Management and execution of external/internal audit program for Santen Korea as per applicable local regulatory and Santen global requirements.
- Provide support to ensure all relevant quality input/support are provided for all relevant post market activities for Santen Korea on time, as per applicable local regulatory authority and Santen's global requirements so as to minimize interruption to supply of quality compliant product.
- Represent Santen Korea as QA Lead to provide relevant QA input/support to selected business projects/initiatives.
- Participate in ad-hoc activities as requested 자격 요건 Education and Experience Requirements
- Successful completion of relevant tertiary qualification – science degree. Registered Pharmacist is a plus.
- At least 5 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.
- Management skills for leading projects and delivery of on-time activities.
- 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 on quality monitoring and management of CMO/Distributor/contract laboratory.
- Good knowledge and experience working with regulators
- Good knowledge of local regulatory requirement on local product secondary repackaging and local product testing.
- Good knowledge and experience on performing quality operation activities and understanding the regulatory requirements for the importation, repackaging, release, storage and distribution of pharmaceutical and medical devices products is preferred.
- Direct knowledge and experience in working with cGMP and quality management system elements and guidelines (e.g. PIC/S, ICH, ISO9001 or ISO and cold chain product repackaging.
- Experience in supporting supplier audits, internal audits, regulatory authority inspections.
- Ability to work independently and identify compliance risks and escalate when necessary
- Good sense of urgency and strong follow up, ability to manage complex projects and timelines in a matrix team environment
- Demonstrated interpersonal skills including strong negotiation skills, excellent teamwork and coordination skills Key Skills, Abilities, and Competencies
- Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team
- Execute goals and objectives in a driven and a high performance culture, and as applicable with ability to achieve results with non-direct reports
- Organization agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence of stakeholders
- Able to work with a great degree of autonomy, as part of a global virtual team
- Able to work cross-functionally and cross-culturally, in a global business environment
- Ability to manage multiple and complex priorities, and to recognize when a change of priority is needed
- Able to adapt to changes and positively respond to changes
- Enthusiastic, resilient, dynamic, versatile. Display 'Can do' attitude
- Good interpersonal and communication skills
- Excellent verbal and writing skills and fluent in Korean and English. Able to communicate in Japanese language is a plus. 추가 정보 Grow your career at Santen A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. 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.
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Senior QA Executive - Seoul, 대한민국. - Santen Inc
설명
Senior QA Executive (1yr contract)
