Quality Engineer III/IV
Sandoz, a global leader in the rapidly growing generics industry, is a company in which doctors, pharmacists and patients worldwide have placed their trust for more than 100 years. With our 23,000-plus employees in more than 130 countries, we save and improve lives by developing, producing and distributing high-quality, affordable pharmaceuticals. Choosing Sandoz is always "a healthy decision". Through our work and our medicines, we have committed ourselves to improving the quality of life of people the world over. Our future holds many opportunities. Let’s explore them together!
Quality Engineer III/IV
Position Summary:
This position provides Quality Assurance oversight of Manufacturing and Quality Control Laboratories. It performs and supports review and approval of new and existing procedures, investigation documentation, validation, and process control documents. This position leads teams using trend and investigational data to create value through process improvements and failure reduction activities. The incumbent must act independently to identify failure modes, process improvements, and work independently to implement required changes.
In addition to the duties listed above, this position applies advanced quality assurance and quality engineering principles to assure compliance and foster continuous improvement. Incumbent acts as team leader, provides technical traning, and leadership to staff and the site.
Essential Job Functions:
• Provides Quality Assurance oversight for Process, Cleaning and Method Validation and Equipment Qualification.
• Provides review and approval of: Deviations, Investigations, and Inquiries; Protocols/Discrepancies (Validation, Equipment, Process, Production); Methods and Specifications; Change Documentation (CCR, DCM, CAPA).
• Uses data trends to work with operating departments to facilitate process improvements.
• Leads cross functional improvement and process monitoring teams .
• Leads and/or participates in scheduled and unscheduled audits of operational areas.
• Leads teams for tracking of quality activities, metrics, CAPA tracking, etc.
• Provides QA approval on any of the following:
Change Control
Deviations
Lab Inquiries/OOS Investigations
Process, cleaning, method validation protocols, reports and discrepancies
Equipment/facilities qualifications, protocols, and reports
Facility controls/instruments and procedures, etc.
• Acts as lead or participates in internal audits of plant and laboratory operations.
• Interfaces with internal partners to resolve technical issues and initiate process improvements.
• Takes initiative to identify and solve technical and procedural deficiencies to improve quality standards.
• Requires little supervision for most assignments. Receives general instructions for non-standard analyses and projects.
• Interfaces with all levels of management.
• Performs other duties as assigned.
Educational/Professional Requirements:
• BS/BA Degree in Chemistry, Engineering or applicable life sciences field and 7 years of professional related experience.
• Experience in a GMP production environment, cGMP labs, or technical support role.
• ASQ CQE/CQA a plus.
Skills Competencies:
Requires detailed knowledge and experience of applicable processes, validation, and investigation review. Must have sound background/understanding of applied statistics. Experience with Trackwise, SAP, and LIMS/Labware a plus. Must have proven ability to work in a team environment through conflict resolution and negotiations. Requires excellent written and verbal communication skills.
