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Merck

Compare

4.2

based on 311 Reviews

Video summary

141 Merck Jobs

Senior Analyst - Computer System Validation

Merck Ltd

4.2

based on 311 Reviews

1-3 years

Bangalore / Bengaluru

1 vacancy

Senior Analyst - Computer System Validation

Merck

posted 15hr ago

Job Role Insights

Flexible timing

Key skills for the job

Electrical Engineering Pharmacy Computer Science Healthcare Analytical Chemistry Computer System Validation

+ 3 more

Job Description

Work your magic with us!Ready to explore, break barriers, and discover moreWe 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
Your roleWe seek an experienced Senior Analyst - Computer System Validation to support our GxP compliance efforts in our global Data AI Organization
You will be responsible for ensuring that computerized systems and software applications in the data, analytics and AI domain, that are used in regulated environments, comply with industry standards and compliance requirements, with focus on GxP regulations in the pharmaceutical industry (FDA 21 CFR Part 11, EU GMP Annex 11)
This role involves developing qualification and validation strategies, executing validation protocols, and maintaining documentation to support compliance efforts
Key Responsibilities:Develop and execute qualification and validation plans, protocols, and reports for computerized systems and software applications
Collaborate with cross-functional teams to ensure compliance with regulatory requirements and internal policies
Perform risk assessments and impact analyses for computerized systems
Review and approve system specifications, design documents, and change controls
Conduct training sessions for staff on validation processes and compliance requirements
Maintain up-to-date knowledge of regulatory requirements, industry standards, and best practices related to computer system validation
Support audits and inspections by regulatory agencies and internal quality teams
Troubleshoot validation issues and provide solutions to ensure compliance
Who you are:2-5 years of experience in Computer System Validation / GxPBachelors degree with specialization in information systems, computer science, electrical engineering or similarExperience in computer system validation within a regulated industry (pharmaceutical, biotechnology, medical devices, )
Knowledge of regulatory guidelines (eg, FDA, EMA, GxP, GAMP5) and validation methodologies
Experience with software development life cycle (SDLC) and validation tools
As a plus: good hands-on experience with HP ALM or similar, set up workflows, manage signature flows, document/defect lifecycle and changes, liaise with other team members during the project lifecycle phases
Strong analytical and problem-solving skills
Ability to work independently and in a team environment
Excellent written and verbal communication skills in the English language
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 and believethat it drives excellence and innovation, strengthening our ability to lead in science and technology
We are committed to creating access and opportunities for all to develop andgrow at your own pace
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion humanprogress! Apply now and become a part of our diverse team!