QA팀장 > Order

기본정보
포지션명	QA팀장
회사	대기업	직급
외국어		연령/성별	무관
진행절차	서류전형 -> 1차면접 -> 2차면접	마감일	2024-03-11

상세정보

▣담당업무   -  Provide/Handle an oversight on a day-to-day activity for GxP activities which includes multiple clinical studies, clinical/commercial manufacturing, technical transfers, due diligence, product releases, complaints oversight, and GLP non-clinical studies. -  Provide supervisory support to GxP employees. -  Manage, and supervise SKBP Internal Quality Management System (Product Quality Complaints, Change Controls, Deviations CAPAs, SOPs, Internal Audits, external audits, and appropriate employee training programs). -  Manage SKBP External audit program (including CRO/Vendors/CMOs and other vendors audits) for initial qualification, re-qualification and for-cause audit. -  Provide support in reviewing and approving CMOs/CROs/ and Vendors Deviation, Investigations, CAPAs, Quality Agreements, and Change controls -  Assist VP and Head of Quality Assurance with meeting Regulatory requirements, handling regulatory Inspections and assist in managing Post Marketing Commitments, including Quality Management Systems reviews, Annual Product Reviews and Annual Reports -  Assist VP and Head of Global QA with Regulatory Submission reviews (IND, NDA, Information Amendments, Annual Reports (IND/NDA), and other regulatory filings, -  Organization of all QA documents for Inspection readiness at all times -  Review and Approve CAPAs, Investigations, and Product Complaints as required -  Maintain GxP training program. -  Write, revise and maintain/manage local/global SOP, Policies, and work instructions for Quality Assurance. -  Review and approve batch releases for clinical (all programs) and commercial products. -  Provide GCP QA oversight for all clinical studies. -  Provide QA support to IT team for 21 CFR compliance and validation of the software systems. -  Acts as Subject Matter Expert / Point of Contact to provide expertise and knowledge to less experienced auditors, business partners and the core business sector on GxP compliance related issues -  Promote Quality culture for getting things right first time with assurance of data integrity -  Proficient in computer software Word, excel, access, power point etc.   ▣자격/우대 요건   [Education Preferred & Work Experience] -  BS or MS degree in scientific, health care or related discipline -  15+ years of pharmaceutical experience -  Intensive GCP, GMP, GLP and safety background -  Experience with both internal and external audits -  Strong knowledge of development policies, procedures and standards (SOPs, QMS) -  Ability to work with global QA teams in developing CSPV/ GCP/GLP QA -  objectives for audits of investigator sites   [Supervision] -  Supervise GxP team members -  Provide day to day support for the entire QA team, become a key contact in QA team -  communication with VP of QA and Document Management -  Provide the support in managing the consultant QA as needed   [Physical & Mental Requirements] -  Ability to multitask -  Adapts to change -  Maintain composure under pressure -  Ability to follow verbal or written instructions and use of effective verbal communications -  Adapts change, adjust change and grasps information quickly -  Examine and observe details -  At least 20% national and international travel required   ▣근무조건 - 연봉 : 면접 후 협의  - 근무지 : 판교 본사   ▣전형방법 : 서류전형 > SKCT(인성검사) > PT면접 > 임원면접 > 채용검진 > 채용   ▣제출서류  - 영문 이력서/경력기술서/자기소개서를 작성하셔서 이메일 로 보내 주시기 바랍니다.  - 필수 기재사항 : 사진, 생년월일, 지원부문, 최종연봉(기본급/인센티브/기타 수당으로 구분), 희망연봉, 지원이력   ▣서류마감일 : ASAP

담당컨설턴트 정보
이름	곽병국 전무(신)	이메일	beekay@metasearch.co.kr
전화		휴대폰

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