Qualification Engineer - The Staffing Resource Group, Inc
Davie, FL 33314
About the Job
Qualification Engineer
Title: Qualification Engineer
Location: Davie, FL
Industry: Pharmaceutical
Shifts Available: Monday- Friday: 8-5
Salary: Up to $45.00/hr.
Employment Type: 6 month Contract
Environment:
Our client is a global leader in generics and biopharmaceuticals, improving the lives of patients across the world. Today, our portfolio of around 3,500 products is among the largest of any pharmaceutical company in the world. Nearly 200 million people in 60 countries benefit from one of our quality medicines every day. We invest in research and development of generic medicines and biopharmaceuticals, carrying on the legacy of more than a century of finding new ways to help patients improve their lives.
Requirements:
- Recent college graduated with Master s or higher degree
- Must have a minimum of 3 months relevant experience
- Must have worked in a Pharmaceutical manufacturing and/or pharmaceutical formulation and/or pharmaceutical process development program
- Performing investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs)
- Execute the trials and studies in coordination with planning, manufacturing, quality, engineering and PM groups.
Responsibilities:
- Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP s), Standard Operating Procedures (SOP s) .
- Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
- Adapting Operational Excellence (OpEx) initiatives to improve throughput, reduce waste, improve safety of the existing equipment, utilities and facilities. Coordinate activities with various departments and prepare technical reports.
- Performing periodic reviews, statistical assessments, trend analysis and generate leading and lagging KPIs.
- Performing investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs)
- Provide Technical assessments/ product impact assessment summaries on time
- Execute the trials and studies in coordination with planning, manufacturing, quality, engineering and PM groups.
- Review and analysis of the process, analytical and statistical data to support the qualification and validation work. Analysis of data to ascertain the data meets protocol and product acceptance criteria: writes deviation reports and technical assessments as required.
- Identify and coordinate the equipment requirements with R & D, Engineering, Employee Health and Safety (EHS), and PM groups in preparation of Capital Expenditure Request (CER) for the commercial scale pre-validation development/ scale up of the ANDA lots.
- Participation in internal (Corporate and QA audits) and external (FDA, MHRA) audits.
- Remediation of the audit related observations (if any) and timely completion of the action items (if any)
- Maintenance of appropriate documentation of protocols, reports and laboratory note books as required by Standard Operating Procedures (SOPs) and internal policies.
- Lead process and equipment automation and modernization projects, creating automated trending and dashboards
- Actively participate in commercial pre-validation and provide technical support to the manufacturing and quality teams as required.
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
EOE/ADA
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