Qualification Engineer II
10 Days Old
- 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.
- dapting 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)
- Review and analysis of the process, analytical and statistical data to support the qualification and validation work.
- nalysis 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 notebooks as required by Standard Operating Procedures (SOPs) and internal policies.
- Lead process and equipment automation and modernization projects, creating automated trending and dashboards.
- ctively participate in commercial pre-validation and provide technical support to the manufacturing and quality teams as required.
- ny equivalent combination of education, training and/or experience that fulfils the requirements of the position will be considered.
- Requires a college fresh Ph.D. or Master's degree with a minimum of 3 months relevant experience in the field of pharmaceutical manufacturing and/or pharmaceutical formulation and/or pharmaceutical process development and pre-validation in chemistry or chemical engineering or related field.
- Leading multiple new technology introduction, upgrades and automation.
- Responsible for performing additional related duties as assigned.
- Provide Technical assessments/ product impact assessment summaries on time.
- Execute the trials and studies in coordination with planning, manufacturing, quality, engineering and PM groups.
- Location:
- Hollywood
