CSV Consultant

4 weeks ago

Pune, Maharashtra, India Infosys Limited Full time
Job Description

Job Description:

- A day in the life of an Infoscion
- As part of the Infosys consulting team your primary role would be to actively aid the consulting team in different phases of the project including problem definition effort estimation diagnosis solution generation and design and deployment
- You will explore the alternatives to the recommended solutions based on research that includes literature surveys information available in public domains vendor evaluation information etc
- and build POCs
- You will create requirement specifications from the business needs define the to be processes and detailed functional designs based on requirements
- You will support configuring solution requirements on the products understand if any issues diagnose the root cause of such issues seek clarifications and then identify and shortlist solution alternatives
- You will also contribute to unit level and organizational initiatives with an objective of providing high quality value adding solutions to customers
- If you think you fit right in to help our clients navigate their next in their digital transformation journey this is the place for you

Key Responsibilities:

- Key components of the responsibilities are as mentioned below but not limited to
- 6 yrs
- of Professional experience and strong knowledge with real time experience in IT Quality Compliance Computer System Validation Software Testing System Implementation in the Life Sciences industry
- Leads the effort to manage and or maintains validation of the GxP computerized systems
- Create Validation Plan Validation Report and Reviews validation documents such as URS FS FRA DD IQ OQ PQ s TRM
- Assure compliance with GxP GMP GCP GLP privacy requirements
- Develops and maintains IT GxP compliance documentation
- Ensure GxP Computerized Systems are validated as per GAMP 5 requirements
- Stakeholder management and good executor with required communication
- Candidate must have fair conceptual understanding on below key areas
- o IT QMS
- o Validation Qualification
- o Risk management
- o Handling of defects Deviations
- o Investigations
- o CAPA Handling
- o Test Management Compliance
- Candidate must have understating on latest regulations i
- e
- 21CFR Part 11 EU annex 11 and Guidelines e
- g
- GAMP5 guide
- Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i
- e
- standalone enterprise etc

Technical Requirements:

- Hands on experience on testing tools like HP ALM Kneat and SNOW
- Experience to MES QMS Trackwise Lab solutions i
- e
- LIMS Empower CDS Chromeleon Business Analytics Middle wares etc
- will be an advantage
- OT System Qualification Radio ligand Therapy or critical dosage forms will be a plus
- PAS DCS Qualification
- ISA95 High level of understanding
- OT Security will be a plus
- Standalone Systems Qualifications
- PAS DCS Integrated with Manufacturing Equipment qualification

Preferred Skills:

LS Domain->Computer System Validation (CSV)

  • Cyber-CSV

    7 days ago

    Pune, Maharashtra, India Talent Worx Full time ₹ 5,00,000 - ₹ 10,00,000 per year

    We're hiring for one of the world's leading professional services firms, renowned for its commitment to innovation, excellence, and global impact. With a presence in over 150 countries, this organization provides services across consulting, audit, tax, risk advisory, and financial advisory — helping Fortune 500 companies and governments navigate complex...

  • Cyber-CSV

    11 hours ago

    Pune, Maharashtra, India Talent Worx Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    We're hiring for one of the world's leading professional services firms, renowned for its commitment to innovation, excellence, and global impact. With a presence in over 150 countries, this organization provides services across consulting, audit, tax, risk advisory, and financial advisory — helping Fortune 500 companies and governments navigate complex...

  • Integration Consultant

    12 hours ago

    Pune, Maharashtra, India Community Brands Software Development Solutions Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Overview As an Integration Consultant, youll be responsible for building and maintaining an automated exchange of information between iCIMS platform and various external systems utilized by our customers. The ideal candidate comes equipped with implementation experience with demonstrated integration expertise in business and technical verticals. Were...

  • Sap Cpi Consultant

    4 days ago

    Pune, Maharashtra, India Infosys Full time

    Responsibilities A day in the life of an Infoscion As part of the Infosys consulting team your primary role would be to lead the engagement effort of providing high-quality and value-adding consulting solutions to customers at different stages- from problem definition to diagnosis to solution design development and deployment You will review the...

  • Technical Consultant

    10 hours ago

    Pune, Maharashtra, India TraceLink Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Position Overview The Technical Consultant is a key resource on the project implementation team and is responsible for executing technical deliverables to enable our customers to integrate their systems and their supply chain trade partners to TraceLink's Opus Digital Network Platform. This role requires a combination of technical, consultative, and...

  • 28/08/2025) CSV Consultant

    3 days ago

    Pune, Maharashtra, India Infosys Limited Full time

    Job DescriptionResponsibilities :Key components of the responsibilities are as mentioned below but not limited to: 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or...

  • Devops, Cicd/consultant Specialist

    4 days ago

    Pune, Maharashtra, India HSBC Full time

    Job description Some careers shine brighter than others If you re looking for a career that will help you stand out join HSBC and fulfil your potential Whether you want a career that could take you to the top or simply take you in an exciting new direction HSBC offers opportunities support and rewards that will take you further HSBC is one of the...

  • DigiHelic Solutions

    4 weeks ago

    Pune, Maharashtra, India Digihelic Solutions Private Limited Full time

    Work youll do. As a part of our Technology & Transformation team, Youll : - Support on IT quality systems framework design and implementation. - Managing the reviews and assessments for IT quality. - Assist in Computer System Validation (CSV) compliance of GxP processes for pharmaceutical companies or experience on quality compliance services for global...

  • Technical Program Manager

    20 hours ago

    Pune, Maharashtra, India beBeeProject Full time ₹ 1,08,96,000 - ₹ 1,51,52,000

    Senior PMO Consultant - Windchill 13We are seeking a skilled Senior PMO Consultant to lead a major global Windchill v13 Upgrade Project. This is a strategic program within the healthcare and life sciences industry, with high visibility and impact.Job Overview:Lead the planning and execution of a Windchill v13 upgrade, ensuring business continuity, platform...

  • Senior QA Engineer

    2 days ago

    Pune, Maharashtra, India beBeeValidation Full time ₹ 10,00,000 - ₹ 20,00,000

    About our organization:We are a global company providing information technology, consulting and business process services. Our team delivers cloud computing, computer security, digital transformation, artificial intelligence, robotics, data analytics and other technologies.Job RoleYou will ensure the quality and compliance of our systems and processes. Your...