[Janssen] Sr. QA Analyst

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

- 계열사\: 한국얀센(Janssen) 
- 포지션\: Sr. QA Analyst 

- 근무지\: 경기도 화성시

- 근무형태\: 계약직(Fixed term) 1년

[Responsibilities]

1) Establishes and maintains quality assurance programs, procedures and controls, ensuring that

performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives. Monitors and tracks all sources of quality detractors utilizing the service database (e.q. Trackwise, Compliance Wire, Docspace, etc.).

2) Ensures compliance with company policies, procedures, and quality standards; as well as safety and environmental regulations.

3) Develops solutions to database problems of moderate scope and complexity.

4) Writes and assists others in writing standard operating procedures.

5) Generates and identifies significant trends. Regularly reports them to management and appropriate cross functional teams.

6) Provides advanced technical assistance in the use of information mapping technology. Provides support to regulatory filing.

7) Generates moderately complex statistical summaries. Provides support to good manufacturing practice auditing.

[Requirements]

1) Enough experience for reviewing GMP related documents

2) Good technical writing skill

3) Good knowledge in data handling and analysis.

4) Knowledge on quality inspection and audit

5) Knowledge on regulatory filing including analytical method and specification.

6) Knowledge on GMP and related internal/external regulations.

7) Minimum 6 years of experience in related field 

[지원 방법] 
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- J&J Korea Linkedin\: https\://www.linkedin.com/in/country-recruiter-talent-acquisition-296167147/

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