Qualification Owner -R&D

Posté 04 juil. 2022

Bangalore, Karnataka - India

Demander un identifiant 251311



A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Qualification Owner - R&D

The R&D Application team supports the delivery of the R&D service Portfolio for the HealthCare Research (Global Discovery Technology, Global Early Development, External Innovation, Patents & Scientific Services) and Development (Strategic & Business Operations, Global Clinical Development, Global Regulatory Affairs & QA, Global Medical Affairs & Safety).
You will work within the Business Technology (BT) group, as part of the R&D domain organization, covering Biopharma, Consumer Health and assisting as needed with Life Science and Performance Materials. As R&D Qualification Owner, you enable the application delivery team to stay compliant by providing efficient approaches and Services. The Qualification Owner is a employee authorized to manage the Qualification lifecycle of an IT Infrastructure component (e.g. IT System).
* Preserve the qualified state of the IT Infrastructure component all over its lifecycle;
* Create and maintain the qualification documents, as appropriate;
* Responsible for managing the progress of the qualification, about the plan, in close contact with the IT Service Provider and the Service Delivery Manager
* Support the assessment of the proposed suppliers for their impact on qualification of the IT Infrastructure component;
* Support the on-going regulatory compliance of the IT components for defined services;
* Review and approve regulatory system changes and documentation;
* Responsible for the operational tasks of IT Quality Assurance including audit responsibility;
* Conduct periodic review(s) as part of the periodic review of the entire system and compile related reports during operation phase;
* Be the accountable point of contact in matters associated with the qualification.
Minimum Qualifications:
* Minimum of 7 years of experience
* Minimum of Associates Degree or applicable experience within information systems with focus on Qualification of R&D applications
* Previous experience in the biotechnology / pharmaceutical or related industry implementing and validating computer systems that manage regulated information
* Working knowledge of IT infrastructure qualification processes and IT operating procedures
* Knowledgeable in 21 CFR Part 11, GCP and GLP regulations Thoroughly familiar with Quality & GxP IT compliance requirements
* Excellent analytical skills sufficient to lead complex problems resolution, make accurate and consistent interpretations and present high-level reporting for weekly operations meetings and monthly service reviews.
* Ability to familiarize himself / herself independently with entirely new subjects and thus provide comprehensive and innovative solutions
* Excellent written and verbal communications skills
* Working knowledge of information security and best practices
* Proven fast learning & problem management skill



What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!


Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com


If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html