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.

자격요건

[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