Walk-in || Quality Assurance - QMS - Executive/Senior Executive
Aspiro pharma Limited · Hyderabad · onsite · Posted 1d ago
About a minute. You'll make an account on the way through.
About this role
Role & responsibilities
Job Description
1. Job Purpose
To implement, maintain, monitor, and continuously improve the Quality Management System (QMS) in accordance with applicable ISO standards, regulatory requirements, customer requirements, and organizational quality objectives.
2. Key Responsibilities
A. Quality Management System (QMS)
- Implement and maintain the QMS in compliance with ISO 9001 requirements and applicable industry standards.
- Prepare, review, update, and control quality documents, including procedures, work instructions, formats, and records.
- Ensure document control, revision management, and effective distribution of approved documents.
- Monitor compliance with established quality procedures and company policies.
- Coordinate management review meetings and monitor the closure of action items.
- Maintain the QMS documentation system and ensure records are readily available for audits.
B. Internal and External Audits
- Plan and conduct internal quality audits as per the approved audit schedule.
- Coordinate external audits, certification audits, customer audits, and surveillance audits.
- Identify nonconformities, observations, and opportunities for improvement during audits.
- Prepare audit reports and follow up on corrective and preventive actions.
- Ensure timely closure of audit findings and verify the effectiveness of corrective actions.
C. Nonconformity and Corrective Action Management
- Identify, record, investigate, and analyze quality-related nonconformities.
- Conduct root cause analysis using tools such as 5 Why, Fishbone Diagram, and Pareto Analysis.
- Coordinate corrective and preventive actions (CAPA) with concerned departments.
- Track nonconformities, customer complaints, and corrective action status.
- Verify the effectiveness of implemented actions to prevent recurrence.
D. Quality Performance Monitoring
- Monitor quality objectives, KPIs, and performance indicators.
- Prepare periodic quality reports, dashboards, and trend analysis.
- Track process compliance, audit performance, and customer complaint trends.
- Support continuous improvement initiatives to enhance process effectiveness and reduce quality risks.
E. Training and Awareness
- Coordinate QMS awareness and quality-related training programs.
- Maintain training records and competency matrices.
- Promote quality culture and awareness of applicable procedures and standards across departments.
F. Cross-Functional Coordination
- Coordinate with Production, Operations, Engineering, Purchase, Stores, HR, and other departments for QMS implementation.
- Ensure process owners comply with approved procedures and quality requirements.
- Support risk-based thinking, process improvement, and change management activities.
- Assist in preparing and maintaining risk registers, process maps, and quality-related documentation.
G. Customer and Regulatory Compliance
- Support the handling and investigation of customer complaints and quality issues.
- Ensure compliance with applicable statutory, regulatory, contractual, and customer-specific requirements.
- Maintain quality records and documentation required for customer and certification audits.
- Support supplier quality evaluation and improvement activities, where applicable.
3. Required Qualifications
- Bachelor's degree or diploma in Engineering, Science, Quality Management, or a related discipline.
- Additional qualification or certification in Quality Management Systems is preferred.
- ISO 9001:2015 Internal Auditor or Lead Auditor certification preferred.
4. Experience
- 36 years of relevant experience in Quality Assurance, QMS, quality documentation, and auditing.
- Experience in implementing and maintaining ISO-based management systems.
- Experience in handling internal audits, external audits, CAPA, and root cause analysis.
- Industry-specific experience is preferred.
5. Required Skills and Competencies
- Good knowledge of ISO 9001 requirements and QMS implementation.
- Strong documentation and document control skills.
- Knowledge of internal auditing techniques and audit reporting.
- Proficiency in root cause analysis and corrective action management.
- Good analytical, communication, coordination, and problem-solving skills.
- Proficiency in MS Office, Excel, and quality reporting tools.
- Ability to coordinate effectively with cross-functional teams.
- Strong attention to detail and commitment to continual improvement.
6. Key Performance Indicators (KPIs)
- Percentage of internal audits completed as per schedule.
- Timely closure of audit nonconformities and CAPA.
- Effectiveness of corrective actions and reduction in recurring nonconformities.
- QMS document review and revision compliance.
- Achievement of quality objectives and departmental targets.
- Timely completion of management review action items.
- Customer complaint closure time and recurrence rate.
- Completion of planned quality awareness and training programs.
7. Authority and Accountability
- Responsible for monitoring QMS compliance and reporting deviations.
- Authorized to raise audit findings and request corrective actions from process owners.
- Accountable for maintaining accurate QMS documentation and audit records.
- Responsible for coordinating QMS improvement activities and reporting quality performance to management.
8. Working Relationships
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Skills
About Aspiro Pharma

Aspiro pharma Limited
Pharma
175
employees
2012
14 years old
Bangalore,Karnataka
India
₹5.5L PA avg
Avg at Aspiro Pharma
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3.0
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2.3
Work-life
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