Σχετικά με την εργασία
The MFQ Specialist is responsible for providing Quality oversight to all manufacturing and packaging areas to ensure product quality and SOP/GMP compliance. The MQA Specialist 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 aseptic conditions within clean rooms with a focus on
Sterility Assurance during manufacturing operations
• Provides review of production specific Deviations / Investigations, CAPAs, Change Controls
• Assist in generating procedures related to Manufacturing QA functions / activities
• Periodically review records to verify that quality standards for each drug product is met
• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
• Prepares weekly/monthly reports, prepares metrics 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.
• Assist CAPA teams, and other project teams, in the development of action plans and implementation
schedules, and the verification of completed actions.
• Conduct periodic internal reviews or audits to ensure that compliance procedures are followed.
• Conduct and report the findings of internal investigations of compliance issues.
Ξεχωρίστε από το πλήθος
• BS/BA 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 with a focus on Sterility Assurance
• 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
Τι προσφέρεται;
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.