Senior Validation Analyst

3 days ago

Bengaluru Coimbatore, India Sikich Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Sikich is seeking an experienced Validation Analyst to join our dynamic team and contribute to our commitment to quality and compliance in the field of computer systems validation.

About the firm

Sikich is a global company specializing in Accounting, Advisory, and Technical professional services. With employees across the globe, Sikich ranks as one of the largest professional services companies in the United States. Our comprehensive skillsets, obtained over decades of experience as entrepreneurs, business owners and industry innovators, allow us to provide insights and transformative strategies to help strengthen every dimension of our clients businesses.

Experience Band: 5 - 8 years

Primary Job Responsibilities:

  • Develop and maintain validation protocols (PQ, IQ, OQ) for computerized systems, ensuring they meet regulatory requirements and internal standards
  • Must have prior work experience on TrackWise and/or TrackWise Digital Validation.
  • Execute validation protocols, document test results, and generate comprehensive validation reports
  • Identify and resolve validation issues and deviations in a timely manner
  • Conduct thorough dry runs of validation protocols to ensure readiness for formal execution
  • Lead formal execution activities, coordinating with cross-functional teams to ensure successful validation
  • Collaborate effectively with cross-functional teams, including IT, Quality Assurance, and Regulatory Affairs
  • Provide guidance and support to team members to ensure the successful completion of validation
  • Develop and review Functional Requirement Specifications (FRS) for computer systems, ensuring they align with user needs and regulatory requirements
  • Create and maintain validation plans, outlining the overall validation strategy and approach for each project
  • Maintain a repository of training materials and documentation related to computer systems validation
  • Provide training to the team members and end-users on validation processes and best practices

Requirements:

  • Computerized system validation (CSV), including knowledge on FDA 21, CFR Part11 and GAMP
  • Must have TrackWise and/or TrackWise Digital Validation experience.
  • Experience in electronic / paper-based execution methods.
  • Veeva QMS and HP ALM tool knowledge is an added advantage.
  • At least one year of experience in Life sciences domain and CSV.

Must Have Life Skills:

  • Ability to multitask by handling more than one client project at the same time
  • Excellent Analytical and problem-solving skills
  • Proven understanding of existing project
  • Must be Self-driven as well as ability to learn, provide solutions both independently and with team is essential
  • Good communication ability and technical presentation ability (oral and written)

Technologies / Domain:

  • TrackWise / TrackWise Digital
  • Knowledge of Scripting

Nice to Have:

  • Knowledge of the Agile methodology and experience working on a scrum team

Benefits of being a part of the team

  • Family Health Insurance including parents
  • Life & Accident Insurance
  • Maternity/paternity leave
  • Performance-based incentives
  • Referral Bonus program
  • Exam Fee Reimbursement Policy
  • Indian festival holidays
  • 5 days working week
  • Doctor's Consultation

  • Senior Clinical Validation Analyst

    2 weeks ago

    Bengaluru, Karnataka, India ICON plc Full time US$ 90,000 - US$ 1,20,000 per year

    Senior CVA, Chennai, Office basedICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Senior Clinical Validation Analyst to...

  • Data Validation Analyst

    2 weeks ago

    Bengaluru, Karnataka, India Dev Rabbit IT Solutions Full time

    About the Role :We are seeking a detail-oriented and analytical Data Validation Analyst to join our data quality team. In this role, you will be responsible for validating large datasets, identifying anomalies or inconsistencies, and ensuring data accuracy across our systems and processes. You will work closely with engineering, analytics, and QA teams to...

  • Senior Analyst

    4 days ago

    Bengaluru, India MUFG Full time

    About Us: MUFG Bank, Ltd. is Japan’s premier bank, with a global network spanning in more than 40 markets. Outside of Japan, the bank offers an extensive scope of commercial and investment banking products and services to businesses, governments, and individuals worldwide. MUFG Bank’s parent, Mitsubishi UFJ Financial Group, Inc. (MUFG) is one of the...

  • Model Validation Expert

    5 days ago

    Bengaluru, Karnataka, India beBeeQuantitative Full time ₹ 42,00,000 - ₹ 65,00,000

    Job Title: Senior Analyst - Model ValidationRole Overview:The role of Senior Analyst - Model Validation involves ensuring the accuracy and reliability of quantitative models used in financial decision-making.Key responsibilities include:Conducting independent validation of model methodologies, both initial and periodic, across various asset classes and model...

  • Senior Analyst

    2 weeks ago

    Bengaluru, Karnataka, India MUFG Full time

    About Us:MUFG Bank, Ltd. is Japan's premier bank, with a global network spanning in more than 40 markets. Outside of Japan, the bank offers an extensive scope of commercial and investment banking products and services to businesses, governments, and individuals worldwide. MUFG Bank's parent, Mitsubishi UFJ Financial Group, Inc. (MUFG) is one of the world's...

  • Senior Analyst

    2 weeks ago

    Bengaluru, Karnataka, India MUFG Full time

    About Us: MUFG Bank, Ltd. is Japan's premier bank, with a global network spanning in more than 40 markets. Outside of Japan, the bank offers an extensive scope of commercial and investment banking products and services to businesses, governments, and individuals worldwide. MUFG Bank's parent, Mitsubishi UFJ Financial Group, Inc. (MUFG) is one of the world's...

  • Senior Analyst

    2 weeks ago

    Bengaluru, Karnataka, India MUFG Full time

    About Us:MUFG Bank, Ltd. is Japan's premier bank, with a global network spanning in more than 40 markets. Outside of Japan, the bank offers an extensive scope of commercial and investment banking products and services to businesses, governments, and individuals worldwide. MUFG Bank's parent, Mitsubishi UFJ Financial Group, Inc. (MUFG) is one of the world's...

  • Senior Analyst

    2 weeks ago

    Bengaluru, Karnataka, India MUFG Full time

    About Us:MUFG Bank, Ltd. is Japan's premier bank, with a global network spanning in more than 40 markets. Outside of Japan, the bank offers an extensive scope of commercial and investment banking products and services to businesses, governments, and individuals worldwide. MUFG Bank's parent, Mitsubishi UFJ Financial Group, Inc. (MUFG) is one of the world's...

  • Validation Lead

    1 week ago

    Bengaluru, Karnataka, India Compliance Group Inc Full time

    We are looking for Validation Lead for Compliance Group Inc. High preference to short notice period.Experience : 6 to 12 yearsLocation: Hyderabad (Remote)Develop and implement validation strategies and processes to ensure the quality and reliability of products throughout the development lifecycle.Collaborate with cross-functional teams including...

  • Senior Analyst

    5 days ago

    Bengaluru, Karnataka, India MUFG Full time

    About Us:MUFG Bank, Ltd. is Japan's premier bank, with a global network spanning in more than 40 markets. Outside of Japan, the bank offers an extensive scope of commercial and investment banking products and services to businesses, governments, and individuals worldwide. MUFG Bank's parent, Mitsubishi UFJ Financial Group, Inc. (MUFG) is one of the world's...