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Computer System Validation Specialist (m/f) R%26D

Our Animal Health 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 our planet. This team of energetic, independent thinkers offers one of the industrys 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.

To support our team in Schwabenheim, were looking for a

R&D IT Validation Specialist (m/f)

In this position you will work in interdisciplinary IT projects for the validation of computer systems in the pharmaceutical industry. Under the leadership of Associate Director R&D Compliance and GLP IT Contact, this position will work in R&D IT projects in the field of animal health to support and implement validation activities. This includes change management, the creation and review of technical documentation in accordance with the requirements of the System Development Lifecycle (SDLC) and GxP (e.g. technical specifications, quality assurance plan and report, standard operating procedures and work instructions).

The Validation Specialist will work in various intercultural local and virtual global teams in cooperation with business representatives, quality assurance and different IT groups in the validation of computer systems.

Your Tasks:

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Act as a subject matter expert in computer system validation

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Write SDLC documents like quality assurance plan and report, SOPs, test scripts etc.

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Review SDLC documentation including test scripts and reports

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Perform assessment and provide quality advice and consultancy

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Write corrective and preventive action planning (CAPA) and Follow-up

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Partner with Business, Quality Assurance and internal/external IT organizations to ensure the delivery of SDLC validation documentation

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Ensure IT requirements in relation to validation and required documentation are met

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Pro-actively advise and implement compliance improvements

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Support business departments with validation

Your Profile:

* Degree in information technology (IT) or equivalent training

* Proven expertise in writing validation documents using MS Office

* Work experience in IT in the area of validation/qualification

* Expertise in using document management systems like Documentum

* Good knowledge in computer system validation (CSV)

* A demonstrated track record of success in the CSV area

* Good understanding of GxP

* Ability to write in a clear and concise manner, possessing excellent verbal and written communication skills and influencing skills in English and German

* Effective at working within project teams to understand their needs in order translate them into documentation

* A team player who places great emphasis on collective achievements

* Regional / Global and in project management experience preferred is an advantage

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and were counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, were inventing for life.

Computer System Validation Specialist (m/f) R%26D

MSD
United States
Full Time

Published on 11/02/2021

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