Experience in analysis of Solid Oral - FP, Instrumentation, In-process or Stability. Experience of Analytical Method Validation. Experience of PMQC & Dissolution.
Perform line clearance. In-process venficatoon and batch reconciliation. Investigate deviations, incidents and support CAPA implementation Coordinate equipment qualification, preventive maintenance and calibration activities.
Aspiro Pharma Limited - Speciallities is a USFDA Approved plant and part of the Hetero Group, committed to delivering high-quality sterile injectables to global markets.
The ideal candidate must have hands-on exposure to ophthalmic formulations, along with practical experience in autoclave operations and batch manufacturing processes. A strong understanding of GMP and quality compliance is essential.
Strong knowledge of Quality Agreement / Technical Agreement drafting and review. Practical experience in vendor risk assessment, approved vendor list management and periodic vendor requalification.
Supervises vial manufacturing activities, including dispensing, washing, sterilization, and filling. Manages online documentation for logbooks, BMRs, and BPRs. Executes change controls via TrackWise and updates SOPs, URS, and Quality Risk Assessments to ensure regulatory compliance.