Responsible for quality assurance for secondary manufacturing/formulations
To continuously review quality control processes, procedures and capabilities in order to sustain the most cost effective and efficient methods for meeting quality requirements, and making recommendation for improvement as appropriate.
Review client QC requirements and ensure that quality control documentation for a project meets requirements.
Review and approve Contractor and subcontractor quality control documentation to ensure their planned activities meet contractual requirements
To coordinate all activities required to direct and control manufacturing quality. In particular to review product quality requirements for individual clients and projects, to ensure those requirements are understood and implemented to manage the quality of manufactured items to meet the requirements of the contract specifications.
Manage and control all quality control activities in accordance with identified Quality Assurance standards, company procedures, client specifications and contract requirements.
Assist in production of generic and project specific Method Statements and Risk Assessments.
Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
Process Improvement
Analyzing Information
Strategic Planning
Verbal Communication
Informing Others, Quality Engineering
Emphasizing Excellence
Pharmacology
Attention to Detail
Thoroughness
Dealing with Complexity