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 setting
- 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

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