Masters degree in Biotechnology, Bioengineering or related field 4 years of experience involving the followingbr Transferring drug product processes of parenteral drug products such as biologics or vaccines to fill or finish GMP Manufacturing for clinical and commercial use, integrating and monitoringbr developed processes to plant procedures and equipment capabilities post transfer and lead Life Cycle Management LCM initiatives; Designing, planning, executing, or documenting inbr silico, offline, or online characterization studies and integrating established process operating ranges in recipes, batch records, or other site procedures for new products; Improvingbr Manufacturing performance by establishing monitoring programs, routinely checking for trends, or identifying process improvements and exploring new technologies; Implementing Corrective and Preventive Actions CAPAs and change controls using Trackwise, Integrated Document Management IDM or Organizational Change Management OCM systems; Investigating process deviations to identify root causes and causal factors using tools like Level 0, Fishbone analysis, or contradiction matrix; and Designing and supporting studies that arebr used in regulatory filings that meet the applicable regulations from FDA, EU, or global standards and conduct internal audits to prepare plant for preapproval inspections PAI.br br Section H.14 defines the experience and skills that a qualified candidate must possess to meet the actual minimum requirements for the position. This experience and skills may be obtained in the position offered or any alternate related occupation, regardless of job title.
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