QMS & Audit Compliance: Implementation and maintenance of QMS, document control, internal audits, audit preparation, inspection support and CAPA follow-up.
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.