Quality Assurance QMS

Krishna Placement Services; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Benefits offered by this job

Best in Industry*

Job summary

Krishna Placement Services in Ahmedabad district is seeking a QA/QMS professional to implement and maintain the Quality Management System in compliance with GMP, cGMP and USFDA requirements.

You will manage deviations, CAPA, change controls, OOS/OOT investigations, risk assessments and document control, and review SOPs, BMR, and BPR protocols. The ideal candidate has strong knowledge of QMS, cGMP, USFDA, ICH guidelines, data integrity, and excellent analytical and communication skills.

Qualifications

• Strong knowledge of QMS and pharmaceutical regulatory requirements.
• Experience with GMP/cGMP and USFDA audits.
• Analytical, documentation, investigation and problem-solving skills.

Responsibilities

• Implement and maintain the Quality Management System in compliance with GMP, cGMP and USFDA requirements.
• Manage Deviations, CAPA, Change Controls, OOS/OOT investigations, Risk Assessments and Document Control.
• Review & approve SOPs, BMR, BPR protocols.

Skills

QMS

cGMP

USFDA

ICH guidelines

Data Integrity

Job description

Responsibilities

• Implement and maintain the Quality Management System (QMS) in compliance with GMP, cGMP and USFDA requirements
• Manage Deviations, CAPA, Change Controls, OOS/OOT investigations, Risk Assessments and Document Control
• Review & approve SOPs, BMR, BPR protocols

Required Candidate Profile

Strong knowledge of QMS, cGMP, USFDA, ICH guidelines, Data Integrity and pharmaceutical regulatory requirements.
Good analytical, documentation, investigation, communication and problem‑solving skills.

Perks and Benefits

Best in Industry*