QMS-QC

Emcure Pharmaceuticals Limited; Mhalunge; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Emcure Pharmaceuticals Limited is seeking a QA professional to oversee change control, CAPA and deviation management within a GMP-regulated environment.

The role emphasizes robust documentation, investigation skills, and cross-functional collaboration to ensure compliance with GMP, GLP and global regulatory guidelines. You will monitor quality metrics, participate in audits, and drive continuous improvement across manufacturing and quality systems.

Qualifications

• Experience in deviation, CAPA, and change control handling.
• Good documentation and investigation skills.
• Strong knowledge of GMP and regulatory requirements.
• Laboratory investigations.
• Effective communication and cross-functional coordination.

Responsibilities

• Change Control processes, including impact assessment, approval, and closure.
• Preparation and review of quality documents such as SOPs, STPs, protocols, and reports.
• CAPA management, ensuring timely closure and effectiveness checks.
• Handling and monitoring deviation investigations, OOS/OOT, Lab events, RCA and implementation of CAPA
• Supporting internal and external audits, regulatory inspections, and compliance activities.
• Monitoring quality metrics and trends for continuous improvement.
• Ensuring compliance with GMP, GLP, and regulatory guidelines (WHO, MHRA, USFDA etc.).

Skills

Deviation handling

CAPA

Change control

Documentation

Investigation

GMP/Regulatory

Lab investigations

Communication

Cross-functional coordination

Job description

• Change Control processes, including impact assessment, approval, and closure.
• Preparation and review of quality documents such as SOPs, STPs, protocols, and reports.
• CAPA management, ensuring timely closure and effectiveness checks.
• Handling and monitoring deviation investigations, OOS/OOT, Lab events, root cause analysis (RCA) and implementation of CAPA
• Supporting internal and external audits, regulatory inspections, and compliance activities.
• Monitoring quality metrics and trends for continuous improvement.
• Ensuring compliance with GMP, GLP, and regulatory guidelines (WHO, MHRA, USFDA etc.).

Key Skills Required:

• Experience in deviation, CAPA, and change control handling
• Good documentation and investigation skills
• Strong knowledge of GMP and regulatory requirements
• Laboratory investigations
• Effective communication and cross-functional coordination