Quality Management Systems Senior Specialist

Date: 16.2.2019

Location: Prague, CZ

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Requisition ID: BUS003162

Have you heard about MSD?

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us using technology.

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 MSDQMS 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.


Qualifications

• Master’s Degree in Information Technology, Computer Science, Life or Physical Sciences or related discipline
• Two to Five years of experience in a GXP or QMS environment, or an equivalent combination of education and experience
• Knowledge of GXP and EU regulations including 21 CFR Part 11, Risk-driven System Development Life Cycle (SDLC) methodologies, and Change Management Processes is preferred
• Knowledge of Customer Complaints, Audits, Deviation and Investigation Management processes and other QMS capabilities
• Ability to analyze quality management operations from a data and systems perspective and identify appropriate process and technological improvements
• Hands-on experience with Trackwise, content management applications is a plus.
• Ability to understand technical aspects of IT tools like software and hardware architecture
• Self-Motivated / Self-Starter, will work independently with little direction on routine assignments and work on problems of diverse scope where a solution is not readily apparent
• Technical proficiency, attention to detail, creativity, innovation, and independent thought.

Preferences
• Understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), is beneficial
• Good communication, interpersonal, technical writing skills, proficient computer skills, experience with Document Management Systems  and (preferably) software tools
• Must be conscientious, dependable, adapt well to change, and work effectively with a global / culturally-diverse team.
 

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: Business/Technical Analysis
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD

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