Manager/Sr Manager - QA - API - Kurkumbh

Emcure Pharmaceuticals Limited; Kurkumb; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Emcure Pharmaceuticals Limited in India invites applications for a Manager/Sr Manager Quality - API. You will lead QA activities across API blocks, review and approve change controls, deviations, OOS investigations, CAPAs, QMS documents, SOPs, risk assessments, and validation documents, and supervise batch release/rejection of APIs and materials.

Strong regulatory knowledge and data integrity focus are essential.

Qualifications

• 13–18 years of API QA experience.
• M.Sc in Chemistry required.
• Strong knowledge of cGMP and data integrity.

Responsibilities

• Lead QA activities across API blocks.
• Review and approve change controls, deviations, OOS investigations, CAPAs, QMS documents, SOPs, risk assessments, and validation documents.
• Oversee batch release/rejection of APIs, intermediates, raw materials, packaging materials, and SAP quality transactions.
• Ensure inspection readiness and compliance with regulatory requirements (cGMP, cGLP, Data Integrity).
• Manage internal, customer, vendor, and regulatory audits, including closure of observations.
• Support regulatory submissions and customer interactions.
• Lead QA team recruitment, training, and compliance awareness programs.
• Administer QA activities in SAP, DMS, and LIMS.

Skills

QA leadership

Regulatory knowledge

Change control

Deviations

CAPA

Audits

Data integrity

Batch release

Education

M.Sc (Chemistry)

Tools

SAP quality transactions

LIMS

DMS

Job description

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.