Senior Engineer, Quality

Role Summary

Senior Quality Engineer responsible for Manufacturing Quality Assurance functions within the plant, including deviations resolution, product impact analysis, CAPA, investigations, SOP approvals, calibration oversight, quality improvement programs, and ensuring cGMP and policy compliance.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under responsibility.
• Investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Perform product impact analyses and place product on QA hold where appropriate.
• Maintain an effective liaison with other Quality areas and Plant departments.
• Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approve standard operating procedures; ensure procedures comply with policy and are sensible.
• Approve calibration requests and ensure appropriate product/process limits are assigned.
• Audit commissioning and validation documentation.
• Develop product quality plans, documents and systems, including product specifications, quality specifications, quality plans, risk analyses and FMEA‚Äôs. Develop and implement statistical quality programs and process monitoring systems.
• For specific U.S. manufacturing sites, perform batch release.

Qualifications

• Bachelor's degree, preferably in Biology, Chemistry or Engineering
• 6+ years of overall experience in Manufacturing, Quality or Engineering
• Good verbal and written communication skills
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing