Senior Validation Analyst

2 weeks ago

Bengaluru Coimbatore, India Sikich Full time ₹ 6,00,000 - ₹ 18,00,000 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

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