Position : Sr.Executive/AM - QA ( audits & supplier management)

Location : Maharashtra

Key Responsibilities
1. Audits & Inspection Management (Core Focus)

Lead internal, customer, and regulatory audits end-to-end
Act as primary QA contact during inspections
Plan and execute self-inspections to ensure audit readiness
Drive closure of audit observations and CAPAs within timelines
Conduct mock audits and gap assessments
Coordinate cross-functional audit preparation
Maintain audit records and compliance documentation

2. Supplier Quality & Relationship Management (Core Focus)

Manage supplier lifecycle: qualification, approval, and performance monitoring
Conduct vendor audits for APIs, intermediates, and contract labs
Approve vendor qualification documents and quality agreements
Review and assess supplier changes and risks
Track supplier quality metrics and compliance trends
Lead supplier-related investigations and issue resolution
Act as QA focal point for supplier interactions and escalation

3. Quality Systems

Manage deviations,



CAPA, change control, OOS/OOT, and validation
Implement Quality Risk Management (QRM)
Ensure compliance with GMP/GLP standards

4. Product Quality Oversight

Approve/reject raw materials, intermediates, APIs, and finished products
Review batch records, specifications, SOPs, and validation documents
Ensure stability data supports product lifecycle decisions

5. Compliance & Documentation

Update Site Master File, Validation Master Plan, and Quality Manual
Implement regulatory updates and requirements

6. Investigations & Improvements

Lead/Support deviation, OOS, complaint, and recall investigations
Perform root cause analysis and ensure CAPA effectiveness
Support Annual Product Quality Reviews

7. Training & Collaboration

Deliver training on GMP, data integrity, and quality systems
Work with Production, QC, Engineering, and Supply teams .

📌 Sr.Executive/AM QA (Audit and Supplier Management) (Mumbai)
🏢 Recognized
📍 Mumbai