Manager/Sr Manager - QA - API - Kurkumbh

Position: Manager/Sr Manager Quality - API

Experience: 13-18 Years

Qualification: M.Sc (Chemistry)

• Lead Quality Assurance activities
• Review and approve Change Controls, Deviations, OOS investigations, CAPAs, QMS documents, SOPs, Risk Assessments, and validation documents.
• Responsible for batch release/rejection of APIs, intermediates, raw materials, packaging materials, and SAP quality transactions.
• Oversee process validation, cleaning validation, product quality reviews, recalls, customer complaints, and audit responses.
• Ensure inspection readiness and compliance with cGMP, cGLP, Data Integrity, and regulatory requirements.
• Manage internal, customer, vendor, and regulatory audits, including closure of observations.
• Support vendor qualification, technology transfer, regulatory submissions, and customer interactions.
• Lead QA team recruitment, training, and compliance awareness programs.
• Administer QA-related activities in SAP, DMS, and LIMS, including document control, user management, training, and system compliance.
• Monitor regulatory updates and drive continuous quality system improvements.

Looking for candidates currently at Manager level and leading quality of major API blocks.