A global leading Bio Pharmaceutical Company is seeking a ‘Micro-organism Quality Analyst’ as follow:

- Job Title: Production Process Manager

- Position: Manager / Assistant Manager upto Team Leader

- Division: QC Team

- Location: South Korea

{Responsibilities}

- Bio-burden Testing for Materials, Samples, API & Medical Products

- Microbial Testing Administration for Production Equipment Validation

- Testing Method Validation for Microbial Analysis for each product line

- Disinfectant Efficacy Validation Testing for Production

- Microbial Testing Equipment Validation and Maintenance

- Technology Transfer & Training for Microbial Analysis and Sterility Procedures

- Microbial Analysis Administration (Bio-burden, Endotoxin, Sterility Testing etc…)

- Preparation of Protocol /  Reporting, SOP, Test Log for Microbial Testing

- Impact Evaluation and Reporting of OOS & Deviation of Microbial Testing

- Inspection Response and preemptive Measures for Improvements

{Requirements}

- Bachelor’s Degree

- Major: Microbiology, Life Sciences, Biology etc…

- Microbial Analysis & Test Validation experience

- FDA & EMEA inspection response experience

- Microbial Testing for Production Equipment Validation (BI, EI, GPT)

- Microbial Testing Equipment Validation experience

- Reporting Microbial Impact Evaluation & Deviation experience

- Understanding of Microbial Testing & Sterile Procedures

- Understanding of US and European new Pharma Standards (cGMP, CFR, ICH, USP, EP)

- Working Proficiency in English

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