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Validation Lead - R&D
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.
Validation Lead - R&D
Job Location: Electronic City, Bangalore
Shift Timings: 1:30 pm – 10:30 pm
IT Healthcare R&D shapes the digitization of Healthcare R&D by delivering new IT solutions for Healthcare R&D functions. We are globally represented in Germany, USA and India and are working in a highly regulated environment and compliance is mandatory for both project and service delivery. We have established a Center of Excellence for Validation, Qualification, and Testing and are looking for a Validation Lead (Senior Analyst)
In this role, you will apply your superior subject matter expertise to ensure validation of existing and new computer systems and associated interfaces. The Validation lead is responsible for validation planning and execution, includes the definition of the validation and testing approach and the coordination of the respective resources and activities. You will author key Validation deliverables and ensure high quality output across the team. Applying your organizational and technical understanding, you will onboard team members and prepare and support audits.
Who you are:
- Minimum B.Sc. Degree in Science or Engineering or equivalent
- Proficiency in both written and spoken English
- Minimum of 4 years of combined experience in Pharmaceutical area
(i.e. Validation / Quality Assurance / Project management)
- In depth knowledge of and experience with Computer System Validation and SDLC process
- Intercultural experience and excellent communication skills
- 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
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