Quality Management System - Senior TrackWise Specialist Job

Date: Apr 6, 2019

Location: Prague, CZ

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Requisition ID: BUS002757

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.


Overall Responsibilities:
• Gather and analyze business requirements from cross-functional client groups to design, develop and optimize software applications.
• Perform Trackwise product installation and Upgrade
• Develop technical solutions using the core TW product and utilities - Create workflows, Business rules, TWC automation, Notifications and Migrate updates
• Develop and Implement Crystal Reports / Quality View
• Prepared validation documents System Config/Design Specification (SDS) documents, perform Unit Testing and IQ Documents
• Assist in preparing the Operation Qualification (OQ) test scripts and provided support and guidance for Operation Qualification (OQ) and Performance Qualification (PQ) execution
• Plan and execute the cutover and project Go-LIVE activities
• Transition the knowledge to Operations team for post Go-LIVE
• Delivering Response and Estimation for projects and enhancements
• Familiar with Quality Business Process like Audit, CAPA etc
• Good knowledge of Software Development Life Cycle

Qualifications

Skill and Competency Requirements:

• 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 analyse quality management operations from a data and systems perspective and identify appropriate process and technological improvements
• Hands-on experience with Trackwise, content or workflow 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.

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: Business/Technical Analysis
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Medical, Manager, CAPA, Pharmaceutical, Computer Science, Healthcare, Management, Science, Technology

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