A global leading Bio Pharmaceutical Company is seeking a ‘Batch Record Review Specialist’ as follow:

- Job Title: Batch Record Review Specialist

- Position: Manager / Assistant Manager upto Team Leader

- Division: QA Team

- Location: South Korea

{Responsibilities}

- Build On-the-floor QA system & improvement

- Immediate Remedy for Real-time issues

- Monitoring of On-the-floor QA Status

- Communicate with Clients for Inspections

- Review Production Report and Approval Perfectibility of Documentation

- Build Reviewal, Operation & Improvement of Production Report

- QC System operation of Deviation, OOS & Change Management

- Maintain Production Report for DS (Drug Substance) & DP (Drug Products)

- Administer On-the-floor QA Inspection

- Manage QA System

{Requirements}

- Bachelor’s Degree

- Major: Life Sciences, Chemical Engineering etc…

- GMP work experience

- Production Report Inspection experience

- Biopharma Company work experience preferred

- GMP Production Management experience preferred

- GMP Deviation & Change Management experience preferred

- Understanding of Production Process of Biopharmaceutical Products

- Understanding of Documentation System of GMP

- Understanding for Quality Control System

- English Documentation Capability

Those who are interested in this opportunity, please submit your Resume (CV) 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.

Mobile: 010-8722-1272

Email: ceo@exdigm.com