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Computerized System Compliance Support H/F
WESTBOROUGH MA 01581
Category: Health Care Industry
  • Your pay will be discussed at your interview

Job code: lhw-e0-90664686

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Sanofi Group

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Summary

  Job posted:   Thu Jun 7, 2018
  Distance to work:   ? miles
       
  1 Views, 0 Applications  
 
Computerized System Compliance Support H/F
_Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales ŕ l'international, l'anglais étant la langue de travail._


The role holder will lead the implementation of the GxP computerized systems inspection readiness support provided by CSC to manufacturing sites and countries. Other key responsibilities include performing the Business Quality Representative role for assigned GxP computerized systems and contributing to CS Training and Data Integrity program. Good knowledge of GxPs with operational exposure within the manufacturing and/or clinical context is preferred. Proven ability to assess and communicate GxP compliance requirements and risks given the intended use of the computerized system and associated data integrity issues.


**Key Contributions and Activities -** _in the context of computerized systems GxP compliance_ :


+ Lead the implementation of the inspection readiness support

+ Lead the assigned regional CS Network

+ Perform the Business Quality Representative (BQR) role for assigned systems

+ Contribute to the data integrity program

+ Contribute to creation and update of global quality documents

+ Contribute to design, development and delivery of training

+ Contribute to quality intelligence


**Required Skills:**


+ Good knowledge of GxPs with operational exposure within manufacturing and/or clinical context

+ Proven ability to assess and communicate GxP compliance requirements and risks given the intended use of the computerized system and associated data integrity issues

+ Work autonomously and take operational decisions in line with CSC priorities and applicable Global Quality documents

+ Strong compliance mindset, results-driven, can-do-attitude, solution-oriented, change-agent, patient centric mindset, resourceful, collaborative and innovative


Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.


With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.


Sanofi, Empowering Life


Sanofi achieves its mission, in part, by offering rewarding career opportunities which inspire employee growth and development. Our 6 Recruitment Principles clarify our commitment to you and your role in driving your career.


Our people are responsible for managing their career

Sanofi posts all non-executive opportunities for our people

We give priority to internal candidates

Managers provide constructive feedback to all internal interviewed candidates

We embrace diversity to hire best talent

We expect managers to encourage career moves across the whole organization


A few practical tips:

Be sure to regularly update your Workday profile to simplify the application process

Be aware of any applicable eligibility criteria in the country to which you are applying

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