Operator-Fill/Finish

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Your Role: Operator-Fill/Finish

Filling operator is responsible for filling of injectable and oral liquid. (주사제, 경구제 충전 담당)

Your Responsibilities:

• Filling in aseptic area according to the manufacturing instruction. (제조 지시에 따라 무균 구역에서 충전)
• Responsible for accurately filling. (정확한 충전)
• Safe, effective and efficient set up, operation, and cleaning of aseptic filling machine. (무균 충전기의 안전하고, 효과적이며 효율적인 설치, 작동 및 청소)
• Visual inspection (Inspect and remove defective products via semi-automatic or manual) ((육안검사(반자동 또는 수동으로 결함있는 제품 검사 및 제거)
• Sterilization of filtration filter, rubber stopper, machine components and bottles. (여과 필터, 고무전, 충전 부품 및 병 멸균)
• Disinfection of gamma irradiated materials and introduces them into the sterile area. (방사선 멸균 재료들의 소독 및 무균실로 반입)
• Bottle washing. (세병)
• Perform line clearances. (라인 클리어런스 수행)
• Recording the filling process. (충전 공정 기록)
• Operate filling machine, Autoclave, Hot air sterilizer, semi-automatic visual inspection machine and bottle washing machine. (충전기, Autoclave, 건열멸균기, 반자동 이물 검사기, 세병기 작동)
• Documents information correctly in batch records and area log books. (로그북 및 batch record 기록)
• Manual washing of machine components. (기계 구성 요소 수동 세척)
• Cleans and disinfect aseptic and non-sterile manufacturing areas. (무균 구역 및 비무균 구역 청소 및 소독)
• Ensure housekeeping and safety in formulation (Bulk manufacturing) area. (작업장 정리 정돈 및 청소)
• Support troubleshooting of process deviations in cooperation with line supervisor. (공정 일탈 조치 지원)
• Preventive inspection and trouble shooting()
• Revision of SOP related to work(SOP )

What You Need to Succeed (minimum qualifications):

• Junior college graduate or higher (초대졸 이상)
• Major in pharmaceutical engineering, engineering, technology or science preferred (제약학 또는 이공계 전공자 선호)
• More than 3years of work experience related GMP(GMP3)

What will give you a competitive edge (preferred qualifications):

• Aseptic gowning certification after join the company. (입사 후 무균복 착용 절차 인증)
• Maintain Aseptic gowning certification. (무균복 착용 절차 인증 유지)
• Ability to work in an aseptic environment. (무균 환경에서 일할 수 있는 능력)
• Ability to work with multiple functions in the team. (팀내에서 여러 업무를 할 수 있는 능력)
• Must be able to work and communicate effectively with team members. (팀원들과 효과적으로 일하고 의사소통할 수 있어야 함)
• He/She should be smart enough to identify problem and understanding quality issues. (문제를 파악하고 품질을 이해할 만큼 현명)
• He/She should be keen to address issues originating at his end. (발생되는 문제를 끝날 때 까지 해결하기 위한 열정)
• He/She needs to know and understand how to read and understand standard operating procedure and instructions. (표준작업절차 및 지침을 읽고 이해하는 방법을 알고 이해)
• He/She needs to know and understand how to work in a team and other behavioral skills required to support other teams. (팀에서 일하는 방법과 다른 팀을 지원하는 데 필요한 기타 행동 기술을 알고 이해)
• Able to understand instructions provided in English. (기본적인 영문 독해 능력)
• MS Office(word, excel, PPT) skill : Beginner level or higher

Additional Information:

• Travel: Not required
• Location: Banwol, Korea

Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

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