• 미국계 기업-Quality Assurance Senior Manager(차~부장급)-15년이상+~

Quality Assurance Senior Manager(차~부장급)-15년이상+~미국계 기업

*주요업무

ㆍEnsure a Quality system is in place in compliance with Regulatory and ISO standards.
ㆍLead QA organization( HC 40-45) to implement compliance, supplier quality, design quality, change control and internal audit, Post market surveillance
ㆍExpertise in ISO, GMP international standards
ㆍMake release decisions of finished product after reviewing QC result and Manufacturing record
ㆍLead Quality Management Remediation Project to meet Company quality standards
ㆍLead the team to respond to external audit by regulatory bodies, external stakeholders such as WHO



*자격요건
ㆍLeadership experience in quality systems (> 10 years) in Pharmaceutical , medical device and IVD
ㆍExperience in leadership role in a > 15+ HC, multidiscipline global quality or technical organization
ㆍExperience leading critical quality system improvements or projects including audit corrective action and CAPA, and 483 Observations
ㆍExcellent communication skill in English (in technical writing and conversation)
ㆍExceptional communication skills and ability to facilitate cross-functional cooperation

*우대사항
ㆍPreferred employment in global, international IVD, pharmaceutical firms(>5 years)

*서류접수E-mail : kschoi@hrkorea.co.kr

담당 : HRKorea최경숙부사장

Tel : 02-3450-1263