Manager Quality Assurance - Indústria Farmacêutica/SP

Reports To (Title): Business Director
Function: Quality Assurance
Department: Quality Assurance
This is a working draft based on current business assumptions as of December, 2009. Please note that the successful candidate's level of experience and/or any changes to the business assumptions may result in changes to any or all of the position's accountabilities; required education, experience, knowledge and skills; or title.

OBJECTIVES:
This position implements the quality systems in support of commercial product supply chain in Brazil. The position interacts with company of North America and the company Global Research and Development for manufacturing, quality and regulatory issues related to Brazil product and with Brazil-based vendors for testing, warehouse and distribution operations. This position may serve as the technical responsible person for drug marketing authorization applications.

ACCOUNTABILITIES:
• Ensure timely release of product in Brazil, while assuring product quality and compliance.
• Implement quality systems and continuous process improvement initiatives in order to help grow Quality Assurance and to ensure compliance with locally mandated policies, procedures and processes, where necessary.
• Accountable to QA leadership for investigations into testing, shipping and warehousing non-conformances and deviations to ensure compliant and timely resolution and monitor corrective actions.
• Assist in preparations for interactions with ANVISA.
• Interact with TGRD to obtain information necessary to support regulatory submissions and inquiries from ANVISA.
• Review and approve Brazilian drug marketing authorization applications, and provide appropriate follow-up with ANVISA as requested to ensure approval.
• Perform qualification audits of new or current vendors associated with pharmaceutical distribution or product testing. Ensure performance expectations are met on an ongoing basis.
• Key organizer/participa nt in any inspections (GMP, warehouse, lab) required by ANVISA.
• Work closely with colleagues in TPNA and TGRD to ensure regional regulatory and quality processes are consistent with Takeda's local needs.
• Guarantee communication of all topics related to company's quality assurance ensuring compliance, consistency and accuracy of products and processes
• Additional duties as assigned.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
• Bachelor's Degree in Pharmacy with CRF registration (Regional Council of Pharmacy)
• Minimum of 5 years in related positions, quality management systems or pharmaceutical legislation;
• Knowledge of Local, National and International legislation and regulations;
• Knowledge of quality management systems ISO: 9001:2000, ICH and WHO guidelines;
• Knowledge of Good Distribution Practices and Good Manufacturing Practices;
• Bilingual in Portuguese and English, both written and spoken Preferred;
• Knowledge and experience with pharmaceutical regulations in other Latin America countries;
• Knowledgeable (including some hands-on experience) in the development and validation of analytical methods for drug product (i.e. HPLC, GC, IR, etc.) and formulation development / manufacturing and the relation of these to overall pharmaceutical development;
• Previous experience with the use of contract facilities.

LICENSES/CERTIFICAT IONS:
• CRF registration (Regional Council of Pharmacy)

TRAVEL REQUIREMENTS:
• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
• Requires approximately 15% travel.

Interested please send a resume to edith.aguiar@mribr.com