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Senior Analyst - Validation Lead - R&D
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.
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