Qa Executive-Vapi

Role & responsibilities

Responsible for implementation and maintenance of the Quality Management System and GMP requirements for pharmaceutical glass ampoule/tubular vial manufacturing.

Responsibilities include:

• Prepare, review and maintain SOPs, specifications, formats and quality records.

• Prepare, review and maintain BMRs and related documentation.

• Handle deviations, non-conformances, CAPA, change controls and risk assessments.

• Conduct in-process QA checks and production-document review.

• Support investigation of customer complaints and implementation of corrective actions.

• Participate in customer, certification and regulatory audits and ensure timely closure of observations.

• Conduct internal audits and monitor compliance with SOPs, GMP/GDP and quality systems.

• Conduct employee training on GMP, GDP, SOPs and quality requirements.

• Support equipment/process qualification and validation activities.

• Ensure compliance with ISO 9001 and ISO 15378 requirements.

• Coordinate with Production, QC and Maintenance on quality-related issues and continuous improvement.

• Provide regular reports and KPIs to senior management. Mandatory Skills and Qualifications

• Minimum Bachelors in any relevant field (Chemistry or Engineering background preferred)

• 3-5 years experience in Quality Assurance in pharmaceutical packaging, pharma or a regulated manufacturing environment

• Working knowledge of ISO 9001 standard (knowledge of ISO 15378 preferred)

• Excellent oral and written communication and presentation skills

• Proficiency in Microsoft Office and other basic computer applications

• Proficiency in English