Sr Executive, QMS

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 900,000 - 1,600,000; Full time

Job summary

Amneal Pharmaceuticals in Ahmedabad is seeking a QA/QMS professional responsible for independently conducting investigations on product quality issues, deviations, and OOS/OOT events to ensure timely and regulatory-compliant closure.

You will perform root-cause analyses, drive CAPAs, manage change controls, and generate quality metrics and management reviews. You will support audits, SOP updates, and cross-functional collaboration under cGMP, ALCOA+, FDA/ICH guidelines.

Qualifications

• Strong understanding of QMS principles and compliance.
• Knowledge of GMP, cGMP, GLP, GDP and regulatory requirements.
• Strong attention to detail to identify documentation errors and ensure data integrity.
• Strong written and verbal communication skills for preparing reports and driving quality initiatives.

Responsibilities

• Independently conduct and prepare investigation reports for Product Quality Complaints, Unplanned Deviations, OOS, OOT, and OOAL events with timely regulatory closure.
• Perform root cause analysis using tools (5-Why, Fishbone, Risk Assessment) and recommend CAPA.
• Initiate, review, track, and verify CAPA implementation within established timelines.
• Review and coordinate Change Controls related to processes, equipment, facilities, systems, materials, and documentation, including QMS impact assessments.
• Analyze and prepare annual trend reports for Unplanned Deviations, Complaints, CAPAs, OOS, OOT, OOAL to identify recurring issues.
• Prepare Quality Metrics, Management Review reports, and periodic trend analyses for site leadership.
• Maintain QMS records in compliance with cGMP, ALCOA+, and company procedures.
• Support internal audits, customer audits, and regulatory inspections.
• Assist in development, review, and revision of SOPs and other quality system documents.
• Collaborate with Manufacturing, Quality Control, Engineering, Validation, and cross-functional teams to resolve quality issues.
• Support inspection readiness initiatives and promote continuous improvement of QMS.
• Ensure all activities comply with cGMP, FDA, ICH, company policies, and Health Safety requirements.

Skills

QMS principles

GMP / cGMP / GLP / GDP knowledge

Data integrity awareness

Communication skills

Education

B. Pharm

M. Pharm

Job description

Description

• Independently conduct and prepare investigation reports for Product Quality Complaints, Unplanned Deviations, OOS, OOT, and OOAL events, ensuring timely closure and regulatory compliance.
• Perform root cause analysis using appropriate tools (5-Why, Fishbone, Risk Assessment, etc.) and recommend effective corrective and preventive actions (CAPA).
• Initiate, review, track, and verify CAPA implementation and effectiveness within established timelines.
• Review and coordinate Change Controls related to processes, equipment, facilities, systems, materials, and documentation, including quality and regulatory impact assessments.
• Analyze and prepare annual trend reports for Unplanned Deviations, Complaints, CAPAs, OOS, OOT, and OOAL events to identify recurring issues and drive continuous improvement.
• Prepare Quality Metrics, Management Review reports, and periodic trend analyses for site leadership.
• Maintain QMS records in compliance with cGMP, Data Integrity (ALCOA+), and company procedures.
• Support internal audits, customer audits, and regulatory inspections.
• Assist in the development, review, and revision of SOPs and other quality system documents.
• Collaborate with Manufacturing, Quality Control, Engineering, Validation, and other cross-functional teams to resolve quality issues.
• Support inspection readiness initiatives and promote continuous improvement of Quality Management Systems.
• Ensure all activities are performed in compliance with applicable cGMP, FDA, ICH, company policies, and Health Safety requirements.

Additional Skills

• Strong understanding of QMS principles and compliance.
• Knowledge of GMP, cGMP, GLP, GDP and regulatory requirements from agencies such as the U.S. Food and Drug Administration, European Medicines Agency, and World Health Organization.
• Strong attention to detail to identify documentation errors and ensure data integrity.
• Strong written and verbal communication skills for preparing reports, leading discussions, and driving quality initiatives.

Education

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience

• 5 years or more in 5 - 8 Years

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.