Deputy Manager DQA

Ensure documentation complies with data integrity and compliance with ALCOA+ principles.

• Review of Process development (Development report, risk assessment, Spec. justification etc..) and analytical documents (development reports, spec and MOA and method validation documents).
• Review of Vendor qualification documents
• Ensure effective root cause analysis (RCA) and CAPA for investigations (OOS/OOT/Incidents/deviations).
• Handling of phase gate and Tech. transfer activities.
• Collaborate on resolving any gaps or issues identified during the technology transfer process.
• Oversee DQA requirements during scale-up and technology transfer to manufacturing.
• Foster a culture of compliance, ownership, and continuous improvement.
• Handling of customer calls related to CMS projects and ensuring address of all customers related queries within the timeline.
• Participating in the teleconferences to clarify the customer queries.
• Coordination with Cross-functional teams to meet the project timelines.