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Quality Assurance Manager, Systems

Company: AmerisourceBergen
Location: Sugar Land
Posted on: September 12, 2018

Job Description:

The Quality Assurance (QA) Manager - Quality Systems will lead QA supervisor and associates that perform quality systems related activities and functions throughout the facility. The QA Manager will work alongside other Quality Manager in ensuring compliance to company procedures and regulatory requirements through direct observations and review. S/he will evaluate the operations and other services, provide problem resolution and will recommend any necessary changes. S/he will report to the Site Quality Head.

  • Maintain compliant quality system that adheres to FDA regulatory expectations (including DEA related) both internally and with respect to oversight of the company's suppliers.
  • Host regulatory and customer audits. Maintain the audit preparedness all the time.

  • Responsible for all DEA related activities and controlled substance compliance.
  • Responsible for the maintaining site wide training program and guide training manager/supervisors.

  • Responsible for ensuring that all drug products are compounding in accordance with PharMEDium's quality requirements and in compliance with the cGMPs.
  • Review and approve IQ/OQ/PQ and validation protocols and reports, as applicable, for all manufacturing, testing and packaging activities.
  • Serve as the Lead QA representative on project teams as assigned.
  • Perform internal audits and site walk-throughs of controlled substance processes.
  • Support qualification/validation of GxP related computer based systems; supporting process validation studies and technology transfer as needed
  • Provide recommendations for corrective and preventative action to the functional area groups/teams as well as corporate CAPA management
  • Maintain Quality documentation files, databases, and logs in accordance with established procedural requirements.
  • Write, update and maintain pertinent quality system documents related to: Quality Management review, Metrics, Change Control/Document control, Complaints, training, and Regulatory inspection preparedness and management.

  • Review and approve site specific quality metrics.
  • Participate in Change Control Review Board.

  • Other duties and responsibilities as assigned.

      Bachelor's degree in life sciences. Advanced degree strongly preferred.
    • 6 years' experience in Quality Assurance with demonstrated increasing expertise and responsibility in the pharmaceutical OR biopharmaceutical industry. Preference will be given to applicants who have significant experience in the production of drugs produced by aseptic processing.
    • Ability to influence others and build a company culture of quality
    • Knowledge of FDA regulations with respect to all aspects of drug product production; knowledge of relevant 503B Outsourcing Facility guidance preferred
    • Knowledge of DEA regulation and experience in handling of controlled substance is preferred.
    • Understanding of common aseptic manufacturing processes used in the manufacture of small molecules environment a plus.)
    • Team lead or supervisory experience required.
    • Computer skills in word processing, spreadsheets and databases required.

    • Effective problem solving, supervisory, strong communication (written and verbal) and organizational skills
    • Must be able to communicate technical, scientific, and regulatory information, both written and verbally

      Keywords: AmerisourceBergen, Sugar Land , Quality Assurance Manager, Systems, Executive , Sugar Land, Texas

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