Deputy Manager Quality Management System (QMS)

Why This Role Matters
The Deputy Manager – QMS plays a key role in maintaining and strengthening the Quality Management System within pharmaceutical manufacturing operations. The role ensures compliance with regulatory standards, supports quality investigations, manages supplier quality systems, and contributes to maintaining product quality, safety, and regulatory compliance.

Job Description
The Deputy Manager – QMS will coordinate quality management activities including vendor notifications, complaint handling, quality defect reporting, and supplier quality management. The role also involves supporting regulatory audits, documentation management, and internal quality compliance initiatives to ensure the organization meets international pharmaceutical quality standards.

Key Features of the Role
• Opportunity to work in pharmaceutical quality management and compliance
• Exposure to regulatory audits and inspection readiness activities
• Involvement in supplier quality management and CAPA processes
• Collaboration with cross-functional quality and compliance teams
• Professional growth in pharmaceutical quality systems and regulatory compliance

Responsibilities
• Coordinate vendor notifications, complaints, and quality defect reporting systems
• Initiate and manage Quality Defect Reports (QDRs) and Vendor Notifications (VNs)
• Lead or participate in investigations, root cause analysis, and CAPA implementation
• Identify and communicate quality issues that may affect product safety, efficacy, or regulatory compliance
• Manage supplier quality activities including supplier documentation review and quality agreements
• Coordinate regulatory documentation including updates to the Site Master File and manufacturing authorizations
• Support preparation for regulatory inspections and audits including FDA observations and audit readiness plans
• Prepare and review quality system documentation such as SOPs, deviations, change controls, protocols, and reports
• Coordinate internal self-inspection programs and maintain compliance databases
• Conduct trend analysis and support continuous improvement initiatives in quality systems
• Support training programs for new and existing personnel related to quality compliance
• Provide administrative and compliance support for the Quality department

Required Qualifications

Educational Requirements:
• Bachelor’s Degree in Pharmacy or Chemistry

Experience and Skills:
• Knowledge of pharmaceutical Quality Management Systems (QMS)
• Experience with supplier qualification and quality agreement management
• Strong understanding of CAPA, deviation management, and root cause analysis
• Familiarity with regulatory audit processes and inspection readiness
• Excellent communication and documentation skills
• Ability to collaborate with cross-functional teams in quality and compliance functions
• Strong analytical and problem-solving abilities

Salary Insights:
• Salary details were not specified in the job posting

Company Overview
Amneal Pharmaceuticals is a global pharmaceutical company engaged in the development, manufacturing, and distribution of generic and specialty pharmaceutical products. The company focuses on delivering high-quality medicines while maintaining strong regulatory compliance and quality standards across its global operations.

FAQs
• What qualification is required for this role?
Candidates should have a Bachelor’s degree in Pharmacy or Chemistry.

• Where is the job located?
The role is based in Ahmedabad, Gujarat, India.

• What type of work does the Deputy Manager – QMS perform?
The role focuses on quality management system coordination, supplier quality management, regulatory documentation, investigations, and audit preparation.

• What skills are important for this role?
Knowledge of QMS processes, regulatory compliance, supplier management, CAPA systems, and strong communication skills are essential.

Application Tips
• Highlight experience with pharmaceutical quality management systems
• Mention knowledge of CAPA, deviation handling, and root cause analysis
• Showcase experience supporting regulatory inspections and audits
• Emphasize documentation skills related to SOPs and compliance records
• Include experience in supplier quality management and quality agreements