Senior Specialist, CDS & SDMS, Business Unit

Job Description

Senior Specialist, CDS & SDMS, Business Unit

The Opportunity

• Based in Hyderabad, join a global healthcare biopharma company and be part of a 130- year legacy of success backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
• Be part of an organisation driven by digital technology and data-backed approaches that support a diversified portfolio of prescription medicines, vaccines, and animal health products.
• Drive innovation and execution excellence. Be a part of a team with passion for using data, analytics, and insights to drive decision-making, and which creates custom software, allowing us to tackle some of the world's greatest health threats.

Our Technology Centers focus on creating a space where teams can come together to deliver business solutions that save and improve lives. An integral part of our company's IT operating model, Tech Centers are globally distributed locations where each IT division has employees to enable our digital transformation journey and drive business outcomes. These locations, in addition to the other sites, are essential to supporting our business and strategy.

A focused group of leaders in each Tech Center helps to ensure we can manage and improve each location, from investing in growth, success, and well-being of our people, to making sure colleagues from each IT division feel a sense of belonging to managing critical emergencies. And together, we must leverage the strength of our team to collaborate globally to optimize connections and share best practices across the Tech Centers.

Role Overview

A Business Unit role for the Waters Empower CDS platform will collaborate with site SMEs, and several global groups and functions, to ensure the system is implemented and sustained in compliance.

They will work under guidance of the business system owner, but will be expected to work independently for delivery of specific tasks by agreed dates to ensure the needs of the business are met. This role is expected to be user-facing, gathering user stories and requirements, as well as driving change and adoption of new global processes at a site.

As well as the general sustainment of the system, the role will be expected to assist in the transformation of the system into a fully integrated platform, with global ownership and management of Empower master data as part of the end to end digital laboratory solution.

What should you have :

Primary skills - GxP, BA/ Business analyst, Business Processes for Laboratory Testing, CSA, data integrity, Stakeholder management, Waters Empower CDS and NuGenesis SDMS.

Education:

· Bachelor's degree or equivalent and a minimum of 1 years making a difference in a Pharmaceutical, Scientific, Technology, Engineering, and/or Mathematics field.

· 7+ years

• Good understanding of Business Processes for Laboratory Testing, GxP principles, data integrity, and document control practices.

• Strong collaboration and change management skills, experience of working with and aligning multiple stakeholders such as Global Quality, our Manufacturing Sites, our Research Laboratories, Learning and Development, etc.

• Strong communication and documentation skills, ability to gather information from SMEs, incorporate feedback, author and review procedures, review technical documentation (e.g. Test Protocols).

• Good understanding of System Development Lifecycle (SDLC) activities and Computer System Assurance (CSA)

• Required experience within a regulated laboratory or directly supporting Laboratory processes.

• Experience within a laboratory or directly supporting Laboratory processes preferred. Experience of using Waters Empower CDS and NuGenesis SDMS preferred. Experience of using JIRA for planning and demand management preferred.

•Strong analytic, critical thinking and problem-solving skills

•Attention to detail.

•Self-motivated

•Experience in Pharma Industry with knowledge of cGMP and Laboratory processes.

•Good Communication Skills including fluency in English

Our technology teams operate as business partners, proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver services and solutions that help everyone be more productive and enable innovation.

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing , bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative he