Pharmaceutical engineer vs senior quality engineer

Differences between pharmaceutical engineer and senior quality engineer duties and responsibilities

Pharmaceutical engineer example responsibilities.

• Manage overall validation programs for the GMP products at the manufacturing facility and the contract manufacturing company.
• Participate in regulatory agency inspections (FDA, EU) as a subject matter expert and minimize findings.
• Develop skills in process change control, aseptic technique and gowning, validation, FDA audits and writing manufacturing tickets.
• Prepare installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ) protocols and reports.
• Expedite and simplify the quotation process for solar water heating systems by accurately representing solar water heating system performance through MATLAB models
• Provide plant technical input for all modifications affecting EQ equipment.
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Senior quality engineer example responsibilities.

• Propose design changes on other commodities to achieve gap & flush requirements.
• Provide corporate-wide training and manage contract facilities QMS.
• Develop an equipment specification and manage the project introducing an automate vision inspection system into manufacturing as part of a CAPA.
• Participate in new product development activities including component design reviews, FMEA and control plan development.
• Process planning activities in the extrusion, graphitization and finishing departments.
• Conduct internal AS9100 audits, tracking corrective action to closure and trending analysis.
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