Senior Associate, Quality Assurance Japan

Position Purpose:

Quality Assurance Senior Associate – Japan

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To operate appropriately routine quality events (market release, deviation, complaint and change)in compliance with internal / global CSLB policies and local regulatory requirements

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To collaborate with internal partners, such as sales department, marketing department, medical affairs, regulatory affairs and manufacturing sites

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To appropriately communicate with the local external customers and parties, such as hospital, patients, wholesaler, physicians, J-3PL and laboratories

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To establish new simple and clear operational practices in accordance with the global policy and local regulatory requirements

Reporting Relationships:

The Quality Assurance Senior Associate – Japan reports to:

• Associate Director Affiliate Quality Operations – Japan

Responsibilities and Accountabilities:

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To Operate routine QA activities mainly customer supports, such as complaint handling and query respond in compliance with internal / global policies and local regulatory requirements

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To Collaborate with internal partners

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Manufacturing sites: to manage changes, to request investigation for deviations / complaints and create customer communication letter

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Regulatory Affairs: to manage changes, to check whether or not there’s no discrepancy between the registered dossiers and the actual operation

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Sales and Marketing: to support stable commercial operations, especially complaint handling

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Medical and Regulatory Affairs: to mutually prepare query respond

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To Communicate with external customers and parties (hospital, wholesaler, physician, 3PL, external laboratories)

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To Establish new simple and clear operational practice in accordance with the global policy

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To Oversee projects, if necessary

Position Qualifications and Experience Requirements:

Education

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Bachelor degree or equivalent degree holder

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Intermediate or Advanced level in English (reading and writing, conversation)

Experience

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More than 3 years Experiences in working at Pharmaceutical industries and / or GxP (preferable; GMP and GQP) fields

educational requirements. Refer to local job documentation where applicable.

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