IT Quality-Specialist
Amgen (company site, opens in a new tab)10+ yrsHyderabadOn-siteDirect career pageEst. 20–35 LPA
Posted 7h ago
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Job description
Structured overview of role & requirements
About This Role
- Lead execution of complex validation projects for computerized systems including risk assessments, qualification/validation activities, and regulatory compliance.
- Review and approve validation documentation, change controls, deviations, and ensure adherence to GxP standards and policies.
- Serve as primary QA contact for deviations, CAPA, supplier evaluations, and support regulatory inspections and continuous improvement efforts.
Minimum Requirements
- Master’s degree with minimum 7 years or Bachelor’s degree with minimum 10 years experience in Software and Systems Quality Assurance.
- Strong knowledge of 21 CFR Part 11, EU Annex 11, GAMP, and other GxP regulations (GMP, GLP, GCP, GPvP, GDP).
- Experience managing quality assurance processes including major and minor deviations; proficiency with tools like HP ALM, Jira, Track Wise, LIMS, SAP, or Maximo.
- Must be willing to work from Hyderabad office as per site policy.
Ideal Candidate Profile
- Experienced in independent decision-making and leading quality assurance projects or teams in a regulated pharmaceutical or biotech environment.
- Ability to apply risk-based validation (RBV) and Computer Software Assurance (CSA) methodologies to complex GxP computerized systems.
- Strong analytical skills with working knowledge of data visualization tools (e.g. Power BI) and ability to translate complex data into actionable insights for quality management.