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[담당업무] Lead the improvement projects and or program setting in Quality Management Systems and/or Aseptic process, DS/DP production, EM, Lab. Control, Facilities and Equipment
Audit program (e.g., self-inspection)
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
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[자격요건] 경력사항: 경력(5년 이상 12년 이하)
학력사항: 대학교(4년)졸업 이상 생명공학, 생물학, 미생물학, 화학 등 유관학과
[필수사항] Must have hands on experience in Quality Assurance (deviation handling / batch release process / product complain handling / change control process) or QC analytical / micro Laboratory, DS/DP/Aseptic processing in manufacturing operations, Facilities & Equipment; (HVAC, utility equipment, manufacturing equipment and maintenance and calibration program) Technical 영어 문서 작성 가능자
FDA/EMA 실사 대응 경험자 as an SME cGMP 승인 프로세스 경험자 Must have experience in leading projects Must have excellence organization and time management skills Experienced with regulated GMP environment Must have highly organization skills with the ability to manage multiple tasks in parallel Must have experience working with cross-functional team
[우대사항] 직무기술: 제약
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