Sobre o trabalho
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
Seja a diferença
You possess the following qualifications, background and abilities:
•Pharmacy/ Chemistry/Biology degree with 2 years of pharmaceutical industry experience in quality assurance/quality control or an equivalent combination of education and experience in a scientific or health-rated field
• Minimum 2 years directly related experience supporting compliance in a quality/compliance function/applicable compliance field.
• Ability to effectively communicate
• Decision making ability
• Oversight of operations
• Ability to multi-task and prioritize
• Experience supporting compliance in a quality/compliance/ function /applicable compliance field preferred
• Knowledge of QMS and CAPA related tools or systems is preferred.
• Environmental, monitoring or audit experience is an asset
O que oferecemos?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.