IT Quality Management Systems Senior Specialist
Merck Sharp & Dohme Corp.
Prague, Czech Republic
před 59 dny

Description

Have you heard about MSD?

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-

year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD’s Information Technology division partners with colleagues across the business to help serve our patients and customers around the world.

Ours is a high-energy team of dynamic, innovative individuals dedicated to advancing MSD’s contribution to global medical innovation by leveraging information and technology to efficiently advance the business by driving revenue and productivity.

Who are we looking for ?

We are seeking energetic, forward thinking professionals to join our IT QMS group in Prague. As part of that team, you will be focused on the design, development and delivery of the new or redesigned IT tools that are managing the Quality Management Systems like Deviation Management, Change Control, CAPA, Complaints, and Document Management etc.

You will have the opportunity to work on global teams to identify the biggest opportunities as well as tackle the biggest challenges at the intersection of healthcare, information and technology.

Overall Responsibilities :

  • Understand the critical quality management systems used within MSD and how enhancements to those applications can contribute to continuous improvement of quality management operations across the company.
  • Participate in the development, configuration and delivery of quality management solutions (architecture, detail designs, etc.
  • based on agreed requirements.

  • Support the use of quality management systems / information system across the world.
  • Support and maintain Quality Assurance programs, policies, processes, procedures and controls ensuring compliance with current GMP expectations and established agency requirement and guidelines
  • Technical writing of the life cycle documentation of respective QMS tool
  • Coordinate the activities including internal and externally involved resources to deliver the tool in required quality according the business needs
  • Work closely with Quality owners to gain the understanding the MSD QMS processes
  • Partner with QA Computer Systems Validation team to ensure current guidelines are met in system validations
  • Have a clear understanding of MSD SDLC / GMP / SOP’s and their implications for Computer System lifecycle, and to work in strict accordance with them at all times
  • Strong commitment to continually improve the software development process through process improvements and the use of software tools
  • Work closely with business stakeholders, technical support groups, and QA to thoroughly investigate validation discrepancies and drive best-
  • practice for systems validation;
  • Gain the knowledge of the technical aspects of QMS tools like SW and infrastructure
  • You will become member of IT QMS team and located at Prague IT hub.

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