주요업무 

ㆍLead the improvement projects and or program setting in Quality

    Management Systems

    - cGMP 승인 project manage team의 manager 

    - Apply cGMP knowledge to drive multiple site improvement projects 

       and actions in the vaccine manufacturing plant  

    - Manage multiple, small to medium complexity cross-functional 

       GMP process improvement projects with small to medium size group (2 to 10)

    - Develop and manage project timeline that aligns with the overall site 

       QE timeline

    - Serve as a project manager, tracking overall project timeline and its 

       elements to ensure that functional deliverables are completed on 

       time and according to quality standard

    - Proactively identify project risks and work with the team and a group 

       of SMEs to develop a contingency plan 

    - Prepare a routine project status report  

    - Promote a quality-based GMP culture of collaboration, cooperation, 

       execution, effective communication and cross-functional problem 

       solving to enable high-performance team 

필수사항 

ㆍ학력 : 학사 이상

ㆍ경력 : 5년 이상

ㆍ전공 : 생명공학, 생물학, 미생물학, 화학 등 유관학과

ㆍ영어 능통자

ㆍMust have hands on experience in Quality Assurance

   (example: deviation handling/batch release process/product complain handling/    

    change control process etc.)  

ㆍTechnical 영어 문서 작성 가능자

ㆍFDA/EMA 실사 대응 경험자 as an SME

ㆍcGMP 승인 프로세스 경험자

ㆍMust have experience in leading projects

ㆍMust have excellence organization and time management skills

ㆍExperienced with regulated GMP environment

ㆍMust have highly organization skills with the ability to manage 

    multiple tasks in parallel

우대사항 

ㆍExperienced in cGMP computer system management is a plus