Executive - Quality Assurance (QMS)

Bharat Serums and Vaccines; Mumbai; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Bharat Serums and Vaccines is seeking an experienced Quality Assurance professional to oversee QMS activities, CAPA, deviations and regulatory readiness in Mumbai. The role involves coordinating with vendors, supporting inspections, and ensuring GMP-compliant QA documentation and SOP management.

Ideal candidates bring 4–8 years in pharma QA, hands-on experience with SAP, and strong cross-functional communication skills. A B.Pharm or M.Pharm is preferred, with on-site work in Maharashtra.

Qualifications

• 4–8 years of experience in Quality Assurance within the pharma industry.
• Hands-on experience in QMS, GMP, CAPA, Change Control and Deviation Management.
• Exposure to Vendor Qualification, Vendor Audits and Regulatory Compliance activities.
• Strong knowledge of QA documentation, SOP management and audit readiness.
• Working experience in SAP and pharmaceutical quality systems.
• Good communication, documentation and cross-functional coordination skills.
• Biopharm/pharma qualification preferred.

Responsibilities

• Manage QMS activities including Change Control, Deviations, CAPA, Market Complaints, and Recalls.
• Handle vendor qualification/requalification and conduct audits.
• Support regulatory inspections, management reviews, and compliance initiatives.
• Review QA documentation, SOPs, and ensure GMP compliance.
• Work on SAP-related QA activities and cross-functional coordination.

Skills

QMS implementation

GMP compliance

CAPA & Change Control

Deviation management

Vendor qualification & audits

Regulatory compliance

QA documentation & SOP management

Cross-functional coordination

Education

B.Pharm / M.Pharm

Tools

SAP

Job description

Role & responsibilities

• Manage QMS activities including Change Control, Deviations, CAPA, Market Complaints, and Recalls.
• Handle vendor qualification/requalification and conduct audits.
• Support regulatory inspections, management reviews, and compliance initiatives.
• Review QA documentation, SOPs, and ensure GMP compliance.
• Work on SAP-related QA activities and cross-functional coordination

Preferred candidate profile

• 4-8 years of experience in Quality Assurance within the pharmaceutical industry.
• Hands-on experience in QMS, GMP, CAPA, Change Control, and Deviation Management.
• Exposure to Vendor Qualification, Vendor Audits, and Regulatory Compliance activities.
• Strong knowledge of QA documentation, SOP management, and audit readiness.
• Working experience in SAP and pharmaceutical quality systems.
• Good communication, documentation, and cross-functional coordination skills.
• B.Pharm / M.Pharm qualification preferred.