MDM Validation Associate Analyst

Roles & 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.

Basic Qualifications and Experience

• Master's degree with 1 - 3 years of experience in Business, Engineering, IT or related field OR
• Bachelor's degree with 2 - 5 years of experience in Business, Engineering, IT or related field OR
• Diploma with 6 - 8 years of experience in Business, Engineering, IT or related field

Functional Skills:

Must-Have Skills:

• 2 + years of experience in validation in a G x P -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 HIPPA guidelines .
• Good to have prior work experience in MDM domain
• Hand son experience on JIRA, Confluence
• Professional Certifications
• CSV Certified
• Agile or safe certified