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MDM Validation Associate Analyst
ConfidentialHyderabad / Secunderabad, Telangana26 days ago
Job descriptionMaster'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 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 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
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
Functional Skills : Must-Have Skills :
Good-to-Have Skills :
Skills Required
Gdpr, Alm, Hippa, Problem-solving, Jira
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Mdm Analyst • Hyderabad / Secunderabad, Telangana