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US-: Quality Engineer Pharm Chemicals

Date: 19-Jul-2011
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Quality Engineer Pharm Chemicals

Respond to customer regulatory and quality inquiries. Coordinate the completion of various customer regulatory documents Remain current and knowledgeable on regulatory changes and evaluate their effects and impact on business CDA, change control agreements, QA contract Fill in the questionnaire of supplier quality for customers Scientific and technical support and satisfy the request of customers about regulatory in collaboration with regulatory service in MDA Responsible for all quality complaints for Trackwise workflow and complaints definition Regulatory support for all PCS product portfolio Information and Business unit for new and existing regulatory development Responsible for customer regulatory and quality inquiries. Follow up of all relevant local regulatory development Training of sales and marketing as well as customer on regulatory topics. Creating good relations and advocacy of PCS (MM) interests in industry business organizations and with authorities Effective coordination of strategic activities of experts in global regulatory bodies and business associations Secure flow of information from/to regulatory bodies and business associations and PCS global organization Safeguard PCS BF strategic interests and objectives in arising guidance, standard and regulations Actively participates and represents MM in business associations Builds and keeps personal relationships to local, national and international authorities Coordinates processes with internal functions for the commenting/drafting of guidelines, regulations and standards -Increases the influence of PCS in important regulatory bodies and business associations. Consults and inform global marketing and sales about new trends and developments Coordinates lobbying activities of experts in regulatory bodies and business associations Builds processes for the flow of information and regulatory intelligence within the PCS organisation Decision on the implementation of regulatory requirements after consultation of Marketing and Product -Management Definition of processes to implement upcoming regulatory needs and requirements

BS in Chemistry, Pharmacy, Biology or related Health Science Knowledge of Chemical, pharmaceutical Regulation in VRC, SFDA.

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