18 Sep
|
Medsurge Global
|
Bengaluru
18 Sep
Medsurge Global
Bengaluru
MAIN DUTIES/RESPONSIBILITIES:
The prime responsibility of the role is to support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS). Support QMS documentation, including SOP preparation, review, revision, issuance, and control. Support the management and timely closure of deviations, CAPAs, change controls, and related quality records. Support quality risk management activities and ensure risk-based approaches are applied across QMS processes.
Broadly your duties will include:
To take responsibility for performing assigned QA activities and coordination with cross functional team to support key business initiatives and ensure compliance with all applicable standards.
Key duties of the job include:
QMS Management
· Support the implementation and maintenance of the company QMS.
· Prepare, review, issue, and control SOPs, policies, forms, templates, and other controlled documents.
· Coordinate periodic review and revision of QMS documents.
· Maintain QMS records and ensure proper document traceability.
Deviation,
CAPA & Change Control
· Assist in initiation, tracking, investigation, and closure of deviations, CAPAs, and change controls.
· Coordinate with relevant departments to obtain investigation reports, root-cause analysis, impact assessments, and corrective actions.
· Monitor QMS records to ensure timely completion and closure.
· Support effectiveness checks for CAPAs, where applicable.
Quality Risk Management
Assist in preparation and maintenance of quality risk assessments.
Support risk assessments related to deviations, changes, suppliers, processes, and QMS activities.
Ensure appropriate risk-based approaches are incorporated into QMS processes.
Key Competencies
Attention to detail
Valuable understanding of quality systems
Investigation and analytical skills
Robust documentation practices
Effective stakeholder coordination
Time management and prioritization
Quality and compliance-oriented mindset
📌 Quality Assurance Executive Bengaluru
🏢 Medsurge Global
📍 Bengaluru