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[SK바이오팜] Quality Assurance 팀장 영입

핵심 정보

경력
경력 15년 ↑
학력
대졸(4년제) 이상
근무형태
정규직
급여
면접 후 결정
직급/직책
면접 후 결정
근무지역
경기 성남시, 성남시 분당구
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[SK바이오팜] Quality Assurance 팀장 영입
Quality Assurance 팀장  
주요 업무 QA
[SUMMARY OF POSITION]
ㆍThe Team Leader of GXP Quality Assurance will report to the VP and Head of Global QA.
   This position will be focused on ensuring GXP compliance with regulatory authorities,
   driving and implementing the Company’s compliance directives and supporting quality
   management systems to ensure compliance and minimize risk in a regulated pharmaceutical
   environment.
ㆍThe incumbent will conduct and or participate in all GXP QA audit programs
   which include both internal and external GXP audits.
ㆍThis position will provide day to day support to the VP and Head of Global Quality
   in clinical, Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites
   for development activities, and all relevant vendors to support clinical trials
   including commercial product activities for API.
ㆍThe team leader of GxP Quality Assurance will work with cross functional teams,
   communicate with QA consultants (if necessary) and has contact with external auditees,
   vendors, partners and affiliates.
ㆍThe team leader of GxP Quality Assurance provide support in maintaining internal
   QMS systems, oversee commercial and computer systems validation activities

[DUTIES AND RESPONSIBILITIES]
ㆍProvide/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.
ㆍProvide supervisory support to GXP employees.
ㆍManage, and supervise SKBP Internal Quality Management System
   (Product Quality Complaints, Change Controls, Deviations CAPAs, SOPs, Internal Audits,
   external audits, and appropriate employee training programs).
ㆍManage SKBP External audit program (including CRO/Vendors/CMOs and other vendors audits)
   for initial qualification, re-qualification and for-cause audit.
ㆍProvide support in reviewing and approving CMOs/CROs/ and Vendors Deviation,
   Investigations, CAPAs, Quality Agreements, and Change controls
ㆍAssist 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
ㆍAssist VP and Head of Global QA with Regulatory Submission reviews
   (IND, NDA, Information Amendments, Annual Reports (IND/NDA), and other regulatory filings,
ㆍOrganization of all QA documents for Inspection readiness at all times
ㆍReview and Approve CAPAs, Investigations, and Product Complaints as required
ㆍMaintain GxP training program.
ㆍWrite, revise and maintain/manage local/global SOP, Policies, and work instructions
   for Quality Assurance.
ㆍReview and approve batch releases for clinical (all programs) and commercial products.
ㆍProvide GCP QA oversight for all clinical studies.
ㆍProvide QA support to IT team for 21 CFR compliance and validation of the software systems.
ㆍActs 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
ㆍPromote Quality culture for getting things right first time with assurance of data integrity
ㆍProficient in computer software Word, excel, access, power point etc.

[SUPERVISION EXCERCISED]
ㆍSupervise GxP team members
ㆍProvide day to day support for the entire QA team, become a key contact in QA team
ㆍCommunication with VP of QA and Document Management
ㆍProvide the support in managing the consultant QA as needed
자격요건 필수
[EDUCATION PREFERRED]
ㆍBS or MS degree in scientific, health care or related discipline

[WORK EXPERIENCE]
ㆍ15+ years of pharmaceutical experience
ㆍIntensive GCP, GMP, GLP and safety background
ㆍExperience with both internal and external audits
ㆍStrong knowledge of development policies, procedures and standards (SOPs, QMS)
ㆍAbility to work with global QA teams in developing CSPV/ GCP/GLP QA
ㆍObjectives for audits of investigator sites

우대
[PHYSICAL AND MENTAL REQUIREMENTS]
ㆍAbility to multitask
ㆍAdapts to change
ㆍMaintain composure under pressure
ㆍAbility to follow verbal or written instructions and use of effective verbal communications
ㆍAdapts change, adjust change and grasps information quickly
ㆍExamine and observe details

[OTHER]
ㆍAt least 20% national and international travel required
기타 ㆍ근무지 : 경기도 판교
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서류전형 ㆍ필기ㆍ면접[전공 및 인성] ㆍ최종합격
[주요 일정]
ㆍ서류 접수 : 2/26~3/18
ㆍ필기 및 면접 전형 : 상세 일정 개별 안내
접수기간 및 방법
ㆍ접수기간 : 2024년 03월 11일 15시 마감
ㆍ접수방법 : 홈페이지 지원
* SK Careers 포탈 보수 작업으로 인해 3/11(월)부터 포탈 지원 가능한 점 참고 부탁드립니다
기타사항
ㆍ국가 보훈 대상자 및 장애인은 관련법에 의거 우대합니다
ㆍ석,박사 학위 소지자의 경우 학사를 포함한 전체 학력 정보를 기입해 주시기 바랍니다
ㆍ써치펌과 SK그룹 채용 포털 중복 지원은 불가능 합니다(단, SK그룹 계열사간 중복 지원은 가능)
ㆍ당사 채용 공고 간 중복 지원은 불가능 합니다
ㆍ각 전형 일정은 상황에 따라 조정될 수 있습니다
문의사항
recruit.skbp@sk.com
Designed by saramin

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(13494) 경기 성남시 분당구 판교역로 221 경강선 판교역에서 800m 이내

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접수기간 및 방법

마감되었습니다.

시작일
2024.02.26 00:00
마감일
2024.03.11 15:00

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이동훈
기업형태
코스피, 대기업
업종
의학 및 약학 연구개발업
사원수
269 명 (2024년 기준)
설립일
2011년 4월 1일 (업력 14년차)
홈페이지
www.skbp.com
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