Our client is a manufacturing company of medical devices.

Key Responsibilities

• Monitoring the overall quality of the product.
• Implementing cGMP.
• Giving required training to all new as well as existing employees.
• Implementing ISO and Quality Management System standards.
• Conducting internal quality audit.
• Following up on audit NCs and responsible for clearance of audit NCs well within time.
• Communicating with external agencies for calibration and validation.
• Ensuring validation of the process.
• Preparing dossier for submission to the regulatory authorities.
• Coordinating with the complaint team for the investigation.
• Reviewing and approving documents.
• Ensuring proper implementation of the CAPA.
• Being involved and providing feedback on any root cause investigation.
• Ensuring dispatch verification.
• Releasing batch based on the review of test results.
• Performing supplier audits.
• Archiving and preserving as per the document control procedure.

Job Qualifications

• Minimum 2 years’ experience in the medical device/ pharmaceutical industry is an advantage.
• Bachelor's degree in Pharmaceutical/Medical technology, engineering or related field.
• Working knowledge of ISO 13485 and 9001.
• MS Office and mechanical drawing software are required.
• Fluent in written and spoken English.