Quality Manager

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Job Description

Position Summary:

 

Quality Manager will be responsible for striving to proactively drive the corporate quality culture and promote cGMP activities.

 

Key Activities:

 

  • Leads programs and improvement activities focused on ensuring ongoing effectiveness of the quality management system in accordance with the ISO and GMP requirements.
  • Leads customer complaint investigations requiring direct interaction with customers as well as raw material suppliers.
  • Maintains product specifications, HACCP plans, and other controlled documentation.
  • Manages and leads audit activities within the site including GMP, regulatory, customer and internal audits; recommends and implements activities to close gaps identified in audits to ensure compliance with applicable requirements.
  • Performs internal audits and supplier audits as required.
  • Responsible for maintaining Corrective and Preventive Action program activities within specific scope of responsibility to identify and implement effective corrective actions.
  • Ensures facility cGMP compliance is maintained and identifies/implements improvement programs as required.
  • Provides GMP and GDP training to site personnelWorks with all departments to investigate and resolve process and product quality issues.
  • Performs other duties as assigned with or without accommodation.

 

 

Required Qualification:

 

  • Minimum of Bachelor's degree required; focused degree in Engineering, Scientific, Technical Scientific, or Quality Regulatory Compliance disciplines preferred.
  • Minimum of at least 5 years in pharmaceutical or dietary supplement industry with experience in quality assurance/quality control management role.
  • Proficient knowledge and application of cGMP regulations, specifically FDA 21 CFR Part 110, 111 and 117.
  • Experience in technical writing – SOP’s, non-conformances, etc.
  • Six Sigma, Lean, 5S or ASQ Certification or trainings preferred.
  • Demonstrated excellent time management and organization skills to handle multiple projects and deadlines required.

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Details

Posted: Jul 09, 2020

Type: Full Time

Category: Quality Quality Manager