MDM Testing - Senior Associate Analyst Amgen Technology Private Limited

4.0 - 12.0 years

4 - 12 Lacs

Hyderabad, Telangana, India

On-site

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Plan, coordinate,and executevalidation activities, including qualification and validation of data products and software applications. Developvalidation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reportsand get reviewed and approved Ensure validation strategies meet regulatory requirements and company standards WriteInstallation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documentsand 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, anddata engineeringteams 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. Ensuretimelyand effective completion of all validation activities in line with projectobjectivesand schedules. Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. Identifyopportunities for process improvements in validation activities. Stay current onnew 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,ITor relatedfield OR Bachelor s degree with 2 - 5 years of experience in Business, Engineering,ITor relatedfield OR Diploma with 6 - 8 years of experience in Business, Engineering,ITor related field Functional Skills: Must-Have Skills: 2+ years of experience in validation in aGxP-regulated environment (pharmaceutical, biotech, medical devices, etc.) Experienceof working insoftware validation projects Strong experience on tools like ALM, JIRAetc Must have worked in Agile orSAFeprojects Experience with automated and computer-controlled systems validation (21 CFR Part 11) Proficiencyin developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation Candidate must be able to write validation scriptsin ALM and execute them independently Experiencewith 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 depthknowledge 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 orSAFecertified Soft Skills: Strong analytical abilities to assess and improve master data processes and solutions. Excellent verbal and written communication skills, with the ability to convey complex data concepts clearly to technical and non-technical stakeholders. Effective problem-solving skills to address data-related issues and implement scalable solutions. Ability to work effectively with global, virtual teams

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