Manager, Computerized Systems Validation & QA at Shionogi Inc. in Florham Park, New Jersey

Job Description:

Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company with state-of-the-art research capabilities that has provided innovative medicines essential to people's health for over 140 years.  Shionogi is one of Japan’s oldest pharmaceutical companies, with a presence in over 10 countries and annual global sales exceeding $3 billion.

In the U.S., Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in therapeutic areas such as anti-infectives and CNS. Shionogi Inc. has a U.S. employee base of over 250 people and is actively seeking business development opportunities to expand its presence in the U.S.

Will analyze and perform quality assurance and validation functions in computerized systems in support of pharmaceutical manufacturing GxP guidelines, QMS (Quality Management Systems), applications, and equipment.—and will do so  in accordance with FDA/EMA/PMDA/ICH regulations, 21 CFR part 11//Annex 11 regulation applying Lean Six Sigma principles. 

 RESPONSIBILITIES

• Develop and implement pharmaceutical validation programs and qualification tools to improve process monitoring and optimization.


• Perform internal quality control and assurance audits and participate in vendor audits and provide responses to audit observations.


• Develop and implement Corrective and Prevention Action (CAPA) and Root Cause Analysis procedures using principles of FMEA (Failure Mode Effective Analysis), Six Sigma, Defect/Deviation Life Cycle, (DMAIC) Define, Measure, Analyze, Improve and Control, Change Control, and SDLC.


• Perform Quality Assurance oversight for GxP computerized system activities to ensure compliance with regulatory requirements.


• Review and perform risk analysis/risk management on Change Controls, CAPAs, deviations, and Notice of Events (NOEs) using GxP guidelines.


• Validate GxP computerized systems, Clinical Data Management Systems, EDC applications Medrio, Inform, RAVE and SAS; Support regulatory body inspections.


• Perform gap analysis of validation documentation, systems and practices.

 REQUIREMENTS

• Master’s degree in Chemistry or Pharmaceutical Sciences plus 2 years’ experience in job offered or as Validation Analyst.


• Require skills and knowledge of GxP, EMA, 21 CFR part 11, QMS, DMAIC/ FMEA, Risk Management, Root Cause Analysis, CAPA.


• Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.

To be considered for this position, you must apply and meet the requirements of this opportunity.

We look forward to reviewing your resume & qualifications.

 DISCLAIMER

The job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. 

EEO 

Shionogi Inc. is an equal opportunity/affirmative action employer.

All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.

It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.

Quality Assurance

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