O pracovní pozici
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
• 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.
Vystupte z davu
• 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
• Knowledge of QMS and CAPA related tools or systems is preferred.
• Environmental, monitoring or audit experience is an asset
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.