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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