다음과 같이 국내 유명 바이오 제약회사에서 'QA Team Lead'를 찾습니다.

* Job Title: QA Team Lead

* Position: 팀장 (부장급)

* Experience: 15년 이상

* Location: 경기도

[RESPONSIBILITIES]

- Provide/Handle an oversight on a day-to-day activity for GMP API and Intermediates 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 GMP employees.

- Manage, and supervise company Internal Quality Management System (Product Quality Complaints, Change Controls, Deviations CAPAs, SOPs, Internal Audits, external audits, and appropriate employee training programs).

- Manage company External audit program (including CMO/and or other vendors audits) for initial qualification, re-qualification and for-cause audit.

- Provide support in reviewing and approving CMOs/ 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 GMP/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 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 GMP compliance related issues

- Promote Quality culture for getting things right first time with assurance of data integrity

- At least 20% national and international travel required

[REQUIREMENT]

- 학력: BS or MS degree

- 전공: Scientific, health care or related discipline

- 경력: 제약/바이오 산업 경력 15년 이상

- Internal and External audits 경력 보유자

- Strong knowledge of development policies, procedures and standards (SOPs, QMS)

- Ability to work with global QA teams in developing processes

Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently.

Only qualified candidates will be contacted for interview.

All resumes not contacted will be kept in DB confidentially for future positions.

Kyung Jin KIM

CEO & Executive Search Consultant

Exdigm Inc

Email: ceo@exdigm.com******@*******.***

U. www.exdigm.com