Engineering Consultant
Engineering Consultant
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Salary Not Disclosed
1 Vacancy
Job Description
Job Responsibilities:
Top 5 qualification
-investigations root cause analysis or corrective actions - Critical
-Experience computer system validation - Critical
-Annual product review - Would be nice
-Experience with validation process cleaning or equipment validation - Would be nice
-Any experience around any type of stability program - Would be Nice
Certified Quality Auditor
Preferred
Certified Quality Engineer
Certified Quality Manager
Job Summary
Serves as technical/subject matter expert for compliance quality related issues and works to resolve these issues and improve quality globally. Serves as internal auditor and member of Quality Systems team. Assists in the day-to-day operations of Quality Systems processes including but not limited to Batch Record Review Over the Counter (OTC) Drug and Nutritional Product Release Annual Product Review (APR) Validation Support Change Control Training Document Control Document Distribution Investigation and Root Cause Analysis and Inspection Readiness.
Responsibilities
Quality Management System (QMS) responsible for duties relating to Quality Systems including but not limited to batch record review document control change control annual OTC product review validation support stability support review of quality events and investigation of market quality events. Assist with approaches to continually improve and streamline processes to meet business and compliance requirements including development and incorporation of best practices. Supports additional special projects related to these objectives as required.
Inspection Readiness - Must remain knowledgeable about significant global regulatory changes that could impact client products. Assists with the implementation and monitoring of related systems policies and procedures. Supports efforts to ensure proper compliance quality management systems are maintained and that the global Quality standards are met and consistently followed. Root Cause Analysis Performs and advises on root cause analysis for product quality issues and works issue through containment phase of corrective action process. Supports investigation of internal and external failures to determine cause. Partners with various departments (including Quality R&D Manufacturing Operations Purchasing Package Engineering and Legal) to request input to aid in feedback investigation root cause identification and implementation of actions to respond to both immediate issue resolution and long-term systemic resolution and prevention of recurrence. Follows up to verify that changes in the systems are implemented and monitors the systems over time to verify effectiveness.
Internal Auditor - serves as internal auditor ensures that the site is operating in state of compliance. This includes developing audit plans and performing audits while meeting timeline objectives as well as documenting/ reporting audit results including corrective action plans when applicable. Collaborates with management staff to support the needs of manufacturing while maintaining the client quality standards and with other internal departments to ensure compliance with client policies. Regularly assesses processes to determine if requirements are being met. 20%
Skills & Experience
Experience: 3 years
Field of Experience: quality assurance or quality control
Education: Bachelor/University Degree
Education Focus: Chemistry Microbiologoy
Decision Making: 4-Uses judgment based on the analysis of information
Additional Skills & Abilities
Must have a good understanding of advanced quality principles of audit protocol inspection procedures and FDA and cGMP regulations. Must be familiar with compliance requirements for over the counter (OTC) products. A knowledge and understanding of multiple manufacturing processes/formulations international requirements and bilingual skills are beneficial.
Ability to apply advanced principles theories and concepts and contribute to the development of new principles systems and concepts.
Must be a critical thinker and active listener with good time management ability to provide solutions and define deliverables to a wide range of difficult and complex problems which require the regular use of ingenuity and creativity. Solutions should be imaginative thorough and practicable.
Must have sound and comprehensive oral and written communication skills to interact with various levels of personnel from different cultures both within and outside the company.
Must be able to perform duties under very general direction and independently perform assignments with only general criteria for expected results
Employment Type
Full-time
