Deviation Management Specialist

Profile

Qualification:
S./M.S. degree in appropriate engineering/scientific field
Minimum of 4-8 years post-Bachelor's degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry
Previous experience in writing investigations for atypical events in a manufacturing environment Heavily preferred Familiar with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities
Vendors- Investigation Writing experience is top skillset needed. Technical writing- writing up investigative reports. Position involves a lot of independent work after initial training, but will require collaboration as they will need to interview technicians, etc. to help determine issues Ideal candidate must have investigation, determining root cause experience
Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypical events, development of corrective/preventative actions is required
This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to utilize sound scientific and engineering principles to investigate process deviations
Job Requirements
Deviation, Deviation Management, Process, Report, Investigation, Root cause, Lean , Six sigma, QA, Quality, Quality Analyst , Manufacturing , investigator , cGMP , Pharma, Pharmaceutical, Biotech, Medical Device, laboratory
Job Code:
50125213
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Sanjeev
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