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Spec, Quality, Validation & Compliance Job

Date: Nov 3, 2017

Location: Prague, CZ

Company: MSD

Requisition ID: COM000567

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.


 


 


Join us in the digital health revolution and tackle biggest opportunities and challenges at the intersection of healthcare, information and technology.
Become a member of our IT Global Innovation Center in the heart of Prague with startup atmosphere and flat, friendly and collaborative environment. Enjoy a reward that technology careers do not often bring: the satisfaction of helping to save lives.

Come and be the member of a team that provides regional based SDLC Quality Technical Writing and Quality Approval responsibilities and coordinates with Documentation Administration Services. This includes working with external resources, which will scale up and down based on the demand of capital projects.

This position will partner with Business and other IT groups to support a three tiered service:



  • full quality technical writing;

  • quality technical editing;

  • quality coaching (all services are directly engaged on the projects).

This role may evolve into supporting operational capability of quality approvals and support of SDLC work for all enterprise IT platforms and technologies once they move into operations and maintenance.

Qualifications

Required Experience and Skills:



  • Bachelor's degree in science, engineering, or computer science or equivalent.

  • 2 to 3 years preferred minimum experience in System Development Life Cycle (SDLC), Computer Validation, Quality, Regulatory, Technical, or GxP / non-GxP Operations.

  • 2+ years of relevant experience managing IT Projects and Services.

  • Possesses strong tactical as well as excellent written and oral communications skills.

  • Must be able to work and communicate at all levels and demonstrate a level of professionalism that instills confidence and inspires trust.

  • Experience working in a highly regulated environment and thorough understanding of the System Development Life Cycle for computerized systems.

Primary job responsibilities include:



  • Being a team member of a regional based SDLC Quality Technical Writing and Quality Approval team coordinating with Documentation Administration Services.

  • Working with external resources, which will scale up and down based on the demand of capital projects.

  • Partnering with Business and other IT groups to support a three tiered service: full quality technical writing; quality technical editing; or quality coaching (all services are directly engaged on the projects).

  • Providing guidance to teams regarding MSD System Development Life Cycle Policy requirements.

  • Providing support of SDLC related questions for internal audits, external inspections, and SDLC Assessments/Sustainment.

Besides the great athmosphere we offer:



  • Competitive remuneration

  • Position in a leading global healthcare company

  • Challenging career

  • Professional growth based on performance

  • Innovative and flexible working environment

  • Wide range of benefits

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.



Job: Compliance & Risk Management
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Employee Status: Regular
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Company Trade Name: MSD


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