- Review and approve Vendor Qualification documents and Raw Material Specifications.
- Review Process Development documents, manufacturing processes, and development reports.
- Review and approve analytical, raw material, intermediate, and finished product specifications.
- Review R&D; laboratory validation, stability protocols, reports, and stability studies.
- Ensure quality oversight during Technology Transfer activities with scale-up considerations.
- Review and support Analytical Technology Transfer, Method Transfer (MT), and Method Validation activities.
- Lead and review R&D; failure investigations and implement effective CAPA.
- Provide quality support for Plant and QC investigations related to development products.
- Review Formulation Development documents and Stability Pack design.
- Ensure effective implementation of R&D; Document Management System (DMS) and compliance with cGMP and Data Integrity requirements.
- Review and maintain R&D; data management systems and documentation.
- Review and update pharmacopoeial monographs and internal quality standards.
- Support Regulatory Affairs in DMF compilation, documentation review,



and regulatory submissions.
- Handle regulatory queries and coordinate with cross-functional teams for timely responses.
- Perform Process Failure Mode and Effects Analysis (FMEA) for recent and existing products.
- Participate in Process HAZOP (Hazard and Operability Study) and recommend risk mitigation measures.
- Review and monitor non-routine studies, development trials, and special investigations.
- Conduct Process Risk Assessment and Impurity Risk Assessment to ensure product quality and regulatory compliance.
- Provide quality oversight and review for Process Validation (PV), Cleaning Validation (CV), and Method Transfer (MT) activities.
- Ensure compliance with Quality Management Systems (QMS), ICH Guidelines, GMP, GLP, and applicable regulatory requirements.
- Collaborate with R&D;, Production, QC, QA, Regulatory Affairs, Engineering, and Supply Chain for successful product development and commercialization.
- Drive continuous improvement initiatives, quality risk management, and inspection readiness.

📌 Manager- DQA (Vadodara)
🏢 Exemed
📍 Vadodara