Job Description:

Job Description
PurposeTo ensure that all manufacturing equipment, facilities and systems are qualified, compliant and available for intended production use by effectively planning, executing and closing qualification activities, managing requalification and qualification-related changes, and providing technical qualification support to manufacturing projects and technology transfers without impacting production continuity.Position / Job TitleAsst ManagerDepartmentManufacturing -Qualification.Reporting ToManagerLocationAmbernathYears of Experience10-14 YearsDosage Form
- Solid Orals

Job Responsibilities / Deliverables
- Own the end-to-end qualification lifecycle for manufacturing equipment, facilities, utilities and ancillary systems, ensuring they are qualified and fit for intended use.
- Plan and coordinate qualification activities for recent equipment, facility modifications, process changes and manufacturing projects, ensuring timely completion without impacting production.
- Review, approve and execute qualification strategies,



protocols and reports including IQ, OQ and PQ, ensuring scientific rationale, appropriate acceptance criteria and complete traceability.
- Ensure compliance with cGMP and regulatory requirements throughout qualification execution, documentation and lifecycle management.
- Assess qualification impact of change controls and define requirements for qualification, requalification or additional studies arising from equipment, process, facility and utility changes.
- Own the periodic requalification program, ensuring schedules are proactively planned, monitored and completed within defined timelines.
- Lead qualification deviation management, ensuring effective investigation, root-cause identification, CAPA implementation and timely closure.
- Conduct and review qualification risk assessments to establish appropriate qualification scope, testing requirements and acceptance criteria.
- Provide qualification expertise for technol

📌 Assistant Manager (Ambernath)
🏢 Rubicon Research
📍 Ambernath