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제약 Commercial QA/RA Manager (약사 - 정규직/ Competitive Salary)

지원마감
  • 경력경력
  • 학력대학교 이상
  • 성별무관
  • 급여면접시 협의
  • 근무형태제약/유통
  • 근무지역서울 영등포구 국제금융로 10 (여의도동) 지도

<회사 소개> 
(유)옥시레킷벤키저는 생활용품 및 OTC 의약품 분야의 글로벌 리더인 레킷벤키저(Reckitt Benckiser)의 한국 현지법인입니다. 영국에 본사를 두며, 전 세계 60여개의 국가에서 40,000여명의 임직원들이 근무하고 있습니다. 주요 제품으로는 데톨(핸드워시, 비누, 손 소독젤), 물 먹는 하마, 옥시크린, 이지오프뱅, 피니쉬, 듀렉스, 개비스콘, 스트랩실 등이 있습니다. 한국 법인은 여의도 Two IFC 에 위치하고 있습니다.
(회사 홈페이지: www.rb.com)


지원링크:

https://careers.rb.com/job/Yeongdeungpo-gu-Commercial-QA-&-RA-Manager-Repu-WorkZip_Ye/618397901/


이력서 지원:

rbkhr@rb.com

현재 아래와 같이 Commercial QA/RA Manager를 채용하고 있으니 참고 부탁드립니다.

<채용 포지션>
본 포지션은 태국에 있는 line manager 직접 보고하게되므로, 영어도 필요합니다.

간접보고는 한국 지사장에게 하게됩니다.


약사 자격증 필수

This is a hybrid role of QA / RA Manager. Mainly QA (70%), but RA(30%) responsibilities are given for (functional) cosmetic products. Pharmacist licence is required.
                                                           
 70%

  1. RB Global Quality standards(Manual, SOPs) implementation and Improvement
  2. Ensures Quality improvement ( Quality investigation, FMEA, SPC/SQC application, etc,.)
  3. Lead QC related issues and CAPAs 
  4. Maintain robust and effective change control system 
  5. Training for MicorB / Hygienic factory / Key Quality projects 
  6. To supervise QC lab. and QC data (MicroB, Regulated FGs)
  7. RB QA audits (CAPA,  F/U Monitoring)
  8. To  prepare products technical dossiers and quality standard document
  9. BUSINESS MANAGEMENT SYSTEM
  10. Responsible to develop and implement the global & local Business Management System (BMS) to ensure fully compliant regulated products.     
  11. Work with local functions to develop and maintain all relevant procedures
  12. Develop and maintain robust and effective change control system to ensure compliant Market Authorisations
  13. Product Recall ? establish and communicate responsibilities.   Conduct mock recalls
  14. Train all staff in commercial organisation on all activities required by BMS
  15. Responsible for initial assessment and approval of Distributors & Embellishers handling regulated products
  16. Prepare Technical Agreements for Distributors & Embellishers ? define all expectations (change management, product handling, product release, responsibilities) 




 30%

  • Ensure the registration and regulatory compliance of Reckitt Benckiser’s marketed products with relevant national regulatory requirements to bring competitive advantage to our brands.  
     

Documentation Management System:

  • Ensuring the compilation of national dossiers for submissions to authorities
  • Ensuring the preparation, maintenance and of product registration/license and regulatory compliance files.
  • Ensuring the amendment of registration dossiers as necessary for country-specific regulatory requirements and overseeing the submission of registration/variation applications and negotiating with governmental authorities to obtain rapid approvals.
  • Compiling Compliance Dossiers for manufacturing of products for the local market.
  • Managing and maintaining regulatory documentation filing system.
  • Ensuring the regulatory support for export business (if any)
  • Developing national texts (e.g., PIL, SPC, packaging) including coordination of translations
     
     

Regulatory Requirements:

  • Developing and maintaining a database of local regulatory requirements.
  • Monitoring and interpreting local regulatory issues and trends that will impact the marketability of company products, ensuring that the company is aware of significant local regulatory issues, and proactively leading the development and implementation of strategies to ensure regulatory compliance efforts that result in competitive advantage.

 
Regulatory and Safety Advice

  • Providing regulatory and product compliance expertise in the area of advertising, label claims and printed materials for existing and new products.
  • Protecting key brand and product claims using regulatory expertise.
  • Providing technical support and advice to respond to consumer and legal inquiries, regulatory issues for our products marketed in Korea

Providing advice to Legal and Finance in contract development, relating to medical and regulatory affairs and product safety.

남은 기간 -

시작일2020.10.07

마감일 2020.11.30

  • 지원방법접수링크
  • 입사지원서 -
  • 연락처02-421-6789
  • E-mailrbkhr@rb.com

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