Requisition ID: REG004102
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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 Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck’s Animal Health (MAH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.
The Senior Specialist is responsible for ensuring a current, compliant and efficient quality management system for Merck Animal Health IT systems in US and EU Research and Development Division. This person will also be required to continuously pursue system improvements to optimize the IT QA processes in accordance with current regulations and guidelines.
The Senior Specialist, Quality Assurance –Computer Systems Validation (CSV) will be responsible for providing Quality leadership and support as the Quality Assurance liaison for IT system assessments, validation, change control, process improvements and compliance governance at all applicable points of the System Development Lifecycle (SDLC). This individual will represent Quality on IT projects in support of the SDLC activities, consult on the authoring and conformance of SDLC deliverables and activities in regard to procedures, policies and current regulations, provide QA oversight for system related issues, and employ risk-based methodology. Additionally, the individual will focus on ensuring consistent policy administration, implement key improvement initiatives and solve compliance issues in partnership with business owners.
Education Minimum Requirement:
Required Experience and Skills**:
Preferred Experience and Skills:
Your role at Merck 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 Merck, we’re inventing for life.
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Visa sponsorship is not available for this position.
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Job: Regulatory Affairs Generic
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: No
Company Trade Name: Merck