Sobre o trabalho
The Quality Assurance Supervisor is responsible for providing Quality oversight to all manufacturing and packaging areas to ensure product quality and SOP/GMP compliance. The Quality Assurance supervisor 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.
