IT Quality Management Systems Senior Specialist

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.

• 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
I want to join

I'm applying for:

IT Quality Management Systems Senior Specialist

Privacy Notice and User Agreement

What Personal Information is used and how long is it retained?

Taleo* uses Personal Information such as your name, contact information and other information necessary for the application process. This information may be used by the Human Resources (HR) organization to contact you at any time during your candidacy for employment, to send you announcements, or request other types of information as required. The retention period for Personal Information in Taleo is two years, which is the length of time that the company has determined the information is necessary for the purposes described in this Privacy Notice and User Agreement.

 

Who will have access to Personal Information in Taleo and how will they protect it?

Access to Personal Information in Taleo is limited to you, HR Personnel and limited IT support personnel, based on specific security roles and standard data authorization as outlined for all HR applications. Additionally, some countries utilize third party recruiters that will also have access to the information you input into Taleo. Taleo is hosted by a third party vendor, Oracle, based in the United States. Oracle may also use additional third party vendors to process personal data. Oracle has contractually committed to protect Personal Information and to process it only as instructed by our company, including the destruction of the Personal Information at the end of the retention period. Oracle has certified its compliance with the EU-U.S. Privacy Shield Framework for processing employee related Personal Information.
Access to Personal Information may be from within the country in which the individual to whom the data relates is based, or from any other country in which an authorized user of Taleo is based. While the country from which information is accessed may not have laws that protect Personal Information in the same way as the country in which you are based, all Personal Information in Taleo will be used in accordance with the Global Privacy Notice for Employment-Related purposes , any local privacy notices you receive, all applicable company policies with respect to the privacy and confidentiality of Personal Information, including, but not limited to our Global Privacy and Data Protection Policy and our Global Internet Privacy Policy and any additional requirements of the countries in which the employees to whom the data relate are based.

 

How do I update, correct or delete Personal Information in Taleo?

You have the right to access, rectify and delete your Personal Information that you provide and maintain in your Taleo Profile at any time. You can also request that the information be removed from our database by contacting the company’s Privacy Office. At any time you may decide no longer to use Taleo, raise a concern or make a complaint about your privacy or use or sharing of Personal Information about you by contacting the company’s Privacy Office.

 

End-User Agreement

Your agreement is required to use Taleo. If you agree to the terms, conditions and obligations described in this Data Privacy Notice and User Agreement, click on “I accept”. If you do not agree, do not click on “I accept”, and the application process will discontinue.

 

BY CLICKING “I ACCEPT”, I AUTHORIZE MERCK & CO., INC., KENILWORTH, NJ. USA, WHICH OPERATES AS MSD OUTSIDE OF THE USA AND CANADA TO STORE PERSONAL INFORMATION ABOUT ME IN A DATABASE MAINTAINED BY OUR THIRD PARTY VENDOR, ORACLE CORPORATION, LOCATED IN CHICAGO, ILLINOIS, UNITED STATES (HEADQUARTERED AT: 4140 DUBLIN BOULEVARD, SUITE 400, DUBLIN, CALIFORNIA 94568 UNITED STATES) AND TO PROCESS, TRANSMIT, USE, AND DISCLOSE PERSONAL INFORMATION ABOUT ME FOR PURPOSES OF THE APPLICATION PROCESS, FOR SENDING ANNOUNCEMENTS OF FUTURE JOB OPPORTUNITIES AS THEY BECOME AVAILABLE OR FOR ADMINISTRATION PURPOSES. SUCH DATA WILL BE TREATED IN ACCORDANCE WITH APPLICABLE LEGAL REQUIREMENTS OF THE COUNTRY OF SUBMISSION, THE COUNTRY IN WHICH A POSITION IS LOCATED WHOSE LAWS MAY NOT PROVIDE THE SAME PROTECTION AS THOSE IN THE COUNTRY IN WHICH I AM LOCATED, AND, WHEN USED IN THE U.S., WHERE APPLICABLE, WITH THE COMPANY’S CROSS BORDER PRIVACY RULES POLICY.

 

* What is Taleo?

Taleo is the global web-based applicant tracking platform used by Merck & Co., Inc., Kenilworth, NJ. USA, which operates as MSD outside of the USA and Canada, to enable the Company to source, assess, track and hire internal and external talent. The primary business purpose of Taleo is to facilitate an effective, consistent and efficient company-wide staffing process, through a single, integrated and automated global system of record for candidates and employees. Some collection and input of personal information by candidates in Taleo is required to facilitate the staffing application process. None of the information collected in Taleo is required by law.

 

Note: Merck & Co. Inc Kenilworth, NJ. USA, is known as Merck Sharp & Dohme or MSD in most countries outside of the U.S. and Canada.

Your application has been submitted successfully!
Thank you
Close
Oops, something went wrong :(
Please try again. If problem persist, contact our HR.
Try again Close

Your Internet Explorer is outdated.

This website can not be viewed with your browser!

Upgrade your browser to the latest version (Internet Explorer) or install another browser, like Firefox or Google Chrome