position 외국계 제약사 약사자격 QA
level Manager
location 서울 강남
compensation 협의
firm
summary • Regional QA/QMS expert supporting local QMS/QA staff. The position is split 40/60 between local and regional tasks. • Securing that a QMS system is operational at all sites in the region. • Ensuring compliance to and implementation of relevant authorities regulations, company standards and global SQUID/QMS procedures as appropriate. • Coordinate or perform training on general GDP, GxP, QMS principles and on the global SQUID/QMS procedures as required. • Review effectiveness of global SQUID/QMS and local procedures by participate in local and regional SQUID/QMS management review at regular intervals • Performing GDP, GxP and QMS audit of partners and GEHC MD sites at regular intervals • Reviewing QA compliance before major changes to operations and facilities are implemented • Secure that the necessary QMS contingency plans have been prepared. • Secure that product are stored and distributed according to marketing authorisation (MA) and Product Safety Data Sheets (PSDS) • Provide guidance in validation study design and reporting. To review and evaluate validation protocols and reports, and to be ready to authorize the documents if required. To facilitate the application of best practice through the sharing of knowledge between sites and internal/external experts. • Working closely with the relevant line manager to find the best way forward to achieve cost-efficient improvements of existing quality systems within the area. • Give regional QA guidance/support on complaint handling, investigations, remedy actions and trend analysis of the same • Establish and maintenance of an oversight within QA distribution on all aspects and requirements of storage and transportation of products which support product specifications, cGMP and GDP. • Being prepared to perform international travelling.
responsibilities
requirements

·         Relevant College/University degrees is essential


·         Knowledge of national and international GDP and GMP requirements


·         Expert knowledge of quality systems (ISO, GxP)


·         Experience from pharmaceutical industry is an advantage


·         Product and validation knowledge is an advantage


·         Knowledge of Freight & Transport Industry


·         Ability to represent the company in dealing with internal and external partners


·         Ability to influence internal and external partners to ensure compliance


·         Must be able to work independently, in  an  organized  way,  and  demonstrate  a  positive  "can  do"  attitude, as the direct manager for the position is working in a different time zone and continent. 

status filled
posted on 2011-04-08
   

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