Responsibilities will include:|
- Quality Engineering supports compliance of Actavis with Regulatory and Procedural requirements through performance of multi-faceted statistical analyses using various data sets to identify trends requiring remediation and to recommend Preventive Actions to address them.
- The Quality Engineer is responsible for completion of Annual Product Reviews inclusive of Statistical Process Control (SPC) analysis; Trend Analysis of deviation and complaint investigations, and associated corrective actions; the development and execution of continuous improvement projects; and maintenance of defined QA metrics.
- Prepare Annual Product Reviews in support of FDA / GMP requirements; Perform Statistical analysis for the identification of trends among deviation investigations; Identify and Execute continuous improvement projects applying Lean Six Sigma principles; Identify product related CAPA plans (corrective / preventive actions); Support process related deviation resolution; Provide cross-functional support to other departments, as necessary; Identify quality / compliance related issues; Maintain defined department / site metrics and report to senior management; and Maintain department SOPs and policies.
- Experience in manufacturing or QC testing methods is beneficial. The ideal candidate will be comfortable discussing unit operations and/or analytical methods and capable of performing data entry and basic analysis using MS Excel. Strong writing skills are necessary.
- Bachelor's Degree in Engineering of Sciences with a minimum 1-3 years experience