Quality Assurance 팀장 영입

주요 업무

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QA
[SUMMARY OF POSITION]
○ The 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.
○ The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. 
○ This 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.
○ The 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.
○ The team leader of GxP Quality Assurance provide support in maintaining internal QMS systems, oversee commercial and computer systems validation activities

[DUTIES AND RESPONSIBILITIES]
○ 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.

[SUPERVISION EXCERCISED]
○ 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

자격 요건

필수
[EDUCATION PREFERRED]
○ BS or MS degree in scientific, health care or related discipline

[WORK EXPERIENCE]
○ 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

우대
[PHYSICAL AND 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

[OTHER]
○ At least 20% national and international travel required

기타
○ 근무지 : 경기도 판교 영입 과정

서류 > 필기 > 면접[전공 및 인성] 기타

기타사항
○ 주요 일정
- 서류 접수 : 2/26~3/11
- 필기 및 면접 전형 : 상세 일정 개별 안내

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