Über die Tätigkeit

The Quality Manager is responsible for providing Quality oversight to all manufacturing and packaging areas to ensure product quality and SOP/GMP compliance. The Quality Manager works closely with Operations personnel and Environmental Monitoring Technicians to complete on-the-floor audits and training of behavior and technique.

Responsibilities include, but are not limited to:

• Report on QA events related to maintenance of appropriate conditions within clean rooms with a focus on GMP guidelines as amended by Directive 2003/94/EC, and 91/412/EEC respectively
• Provides review of production specific Deviations / Investigations, Change Controls
• Assist in generating procedures related to Manufacturing QA functions / activities
• Periodically review records to verify that quality standards for each product is met
• Maintain compliance with cGMP guidelines and state laws
• Prepares weekly/monthly reports, prepares metrics (Key Performance Indicators) and trends data to identify and prioritize continuous improvement opportunities
• Responsible to maintain all testing equipment in compliance, calibration and certification
• Promptly communicates with Operations regarding complaints, product issues/variances
• Assists in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation
• Enforce compliance with QA processes, Equipment Qualification, and Computer System Validation principles
• Conduct periodic internal reviews or audits to ensure that compliance procedures are followed
• Conduct and report the findings of internal investigations of compliance issues