QA Validation: Drug Product Support

Location: Remote
Department: Azzur IT, LLC

Job Description

We at Azzur Group are looking for an QA Validation Engineer to join our Azzur Consulting: Philadelphia team.

This position will provide QA technical support for External Manufacturers (EM) in the Americas. Review and approve quality system documents including SOP, specification and manufacturing instructions. Responsible for product release, ensuring products meet cGMP, client specifications and regulatory requirements. Provide QA support for technology transfer and improvement of existing manufacturing processes. Contribute to the overall development, implementation and execution of quality systems in support of to ensure complaint, product quality and product safety. Conduct investigations, perform GMP audits, collect data, analyze trends, and prepare management reports as required. Responsible for continuous improvement and risk management activities of EM.

Key Responsibilities:

  • Reviewing batch documentation and product release
  • Conducting and participating in manufacturing investigations.
  • Reviewing and approving EM deviations
  • Developing corrective action plans and monitoring implementation
  • Review and approve change control
  • Writing and implementing of quality procedures
  • Providing QA support for technology transfer project
  • Identifying and implementing continuous improvements of manufacturing and quality/compliance processes
  • Assess current process and systems and recommend improvements to enhance reliability and reduce cycle time.
  • Analyzing product quality complaints and assisting the external manufacturer to complete complaint investigation
  • Participating in quality audits at external manufacturers.
  • Monitor quality trends, identify issues, recommend, and implement appropriate actions to mitigate risk.
  • Participate and support escalation process and issue management process
  • Support regulatory inspections, manage reporting and monitor follow up on regulatory commitments
  • Maintain Quality Agreement and specification changes.
  • Travel to the EM site to provide on-site GMP oversight and support as needed

Additional Responsibilities and Duties:

  • Providing support to manufacturing / logistics organizations regarding aspects of GMP compliance associated with technology transfer and manufacturing.
  • Remaining current with FDA and local regulations, guidelines, and quality practices associated with the pharmaceutical industry is required.
  • Computer proficiency in Microsoft Office tools with the ability to communicate effectively electronically.
  • Continued development of knowledge and expertise as needed in order to perform job duties.
  • This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned

Qualifications

Education:

  • A minimum of a Bachelor’s Degree or higher is required

Experience & Skills:

  • A minimum of six (6) years of work experience in a FDA regulated environment is required
  • Ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues is required
  • Experience working within a pharmaceutical / biologics manufacturing or quality environment is required
  • Demonstrates knowledge of Quality Assurance, Quality Control and/or Compliance required
  • Proficiency in computer applications such as the MS Office suite is required
  • Position requires a minimum of 30% domestic travel to external manufacturing sites
  • Basic Principles of Aseptic Processing is preferred
  • Experience investigating customer Product Quality Complaints is preferred
  • Advanced Degree is preferred
  • Experience in the development, implementation, and review of SOPs for interactions with contract manufacturers is preferred


 


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