TW Platform Computer System Validation Specialist
Merck Sharp & Dohme Corp.
Prague, Czech Republic
před 59 dny


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.

We offer project-based rotations to help with your professional development, and a flat, collaborative environment. Overall, our new Global Innovation Center in Prague offers technology professionals incredible opportunities to learn from others across the globe, to challenge themselves, and to enjoy a reward that technology careers don’t often bring : the satisfaction of helping to save lives.

We are looking for IT systems specialist, who is eager to learn and to take on the leading the validation strategy and activities of the MSD global platform Trackwise that is used to manage key QMS processes like Deviation management, Change Control, CAPA, Audit management.

The ideal candidate will be involved in all aspects of computer systems validation and qualification activities as part of an overall Software / Product Development Lifecycle (SDLC) approach.

Overall Responsibilities :

  • Define the validation and qualification approach of the Trackwise platform.
  • Maintain the validation documentation in compliance with the MSD procedures and current pharma regulations and industry standards
  • Technical writing of the Trackwise system life cycle documentation.
  • Coordinate the validation / qualification activities including externally involved resources to deliver testing, and documentation.
  • 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 Trackwise platform like SW and infrastructure to support the Trackwise Platform lead.
  • Be able to respond to audit requests and be part of inspection readiness process.
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