Data Validation Specialist

2 days ago

Hyderabad Secunderabad Telangana, India beBeeValidation Full time ₹ 1,04,000 - ₹ 13,08,780
Job Title: MDM Validation Associate Analyst

Overview:

The ideal candidate will possess a strong background in validation, with experience working in software validation projects and tools like ALM and JIRA. A solid understanding of Agile or SAFe methodologies is also required.

Responsibilities:

  • Plan, coordinate, and execute validation activities, including qualification and validation of data products and software applications.
  • Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports and get reviewed and approved.
  • Ensure validation strategies meet regulatory requirements and company standards.
  • Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents and get reviewed, and approved.
  • Stay updated on relevant changes to Amgen's SOPs and ensure validation practices are aligned with evolving standards.
  • Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and data engineering teams to drive validation activities and meet project deadlines.
  • Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan.
  • Ensure timely and effective completion of all validation activities in line with project objectives and schedules.
  • Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management.
  • Identify opportunities for process improvements in validation activities.
  • Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies.
  • Collaborate and communicate effectively with the product teams.

Requirements:

Must-Have Skills:

  • 2 + years of experience in validation in a GxP-regulated environment (pharmaceutical, biotech, medical devices, etc.)
  • Experience of working in software validation projects
  • Strong experience on tools like ALM, JIRA etc
  • Must have worked in Agile or SAFe projects
  • Experience with automated and computer-controlled systems validation (21 CFR Part 11)
  • Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation
  • Candidate must be able to write validation scripts in ALM and execute them independently
  • Experience with computer system validation and software validation is a plus
  • Strong problem-solving and analytical skills
  • Excellent communication and teamwork skills

Good-to-Have Skills:

  • Understanding of compliance and regulatory considerations in master data.
  • In-depth knowledge of GDPR and HIPAA guidelines.
  • Good to have prior work experience in MDM domain
  • Hand-on experience on JIRA, Confluence
  • Professional Certifications
  • CSV Certified
  • Agile or Safe certified

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