[한국존슨앤드존슨] Sr. Analyst Commercial Quality 채용

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한국존슨앤드존슨에서

Sr. Analyst Commercial Quality를 모집 합니다.

Essential Job Duties and Responsibilities

• Responsible activities accompanied by imported product release and in-country testing.
• Responsible for the quality of, and meeting the applicable requirements for, the products that the LOC markets, or the products that it produces for other companies.
• Responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GMP/GDP activities the LOC undertakes.

Imported Product Management

• Maintain SOP/WI related to imported product management including in-country testing
• Document and review required paper set for product release in a timely manner so that products are delivered to customers and patients without delay.

Quality Systems

• Monitor and review Nonconformance and Change Control records related to in-country testing in collaboration with
• External Quality and Regulatory Affairs.
• Implement the Quality System via transposition of the requirements of the Commercial Quality Manual.
• Execute minimum requirements regarding lifecycle management of specification and test method to ensure regulatory compliance and business continuity as a representative of Market Authorization Holder.

Minimum Qualification

• Understanding for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GMP/GDP activities the LOC undertakes. In this role, he/she has defined authority and responsibility for ensuring that quality system and processes are implemented and maintained according to Commercial Quality Manual
• In-depth knowledge for the specification & test method relate with chemical & biological drug products
• Up-to-date knowledge of relevant pharmaceutical legislation and GxP including but not limited to GMP/GDP;
• Good understanding of quality management system and local regulation
• Fluent in English spoken and reading
• Strong conversation skills with different internal/external stakeholders

Other requirements

• Excellent time management skills
• Conversation skills with different internal/external customers and stakeholders

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https://www.careers.jnj.com/en/jobs/r-053985/innovative-medicine-sr-analyst-commercial-quality-contractor/