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.

📌 Manager/Sr Manager - QA - API - Kurkumbh (Pune)
🏢 Emcure
📍 Pune