Seeking a detail-oriented contractor to support
Document Specialist/Operations Investigator
in a pharmaceutical environment Responsibilities
Investigation of manufacturing and packaging deviations and non-conformances to determine root cause and implementation of Corrective and Preventative Actions (CAPAs) to prevent recurrence. Work with cross-functional teams to gather data, lead, and perform Root Cause Analysis to determine the likely root cause of the event. Preparing investigation reports that include recommendations on investigation findings for medium/high severity non-conformances and communicating findings and recommendations at group meetings. Ability to conduct in-depth interviews and gather pertinent information to drive root cause conclusions, product impact analyses, and initiations of CAPA actions. Reviewing completed Batch manufacturing Records (BMR) and logbooks following cGMP standards in support of investigations. Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) following cGMP standards to ensure compliance with written procedures. Monitoring production processes to acquire vital data in support of investigations and track the efficiency of changes. Gathering, trending, and analyzing process-related data to drive consistency and timeliness. Training new employees in investigative processes and techniques and documenting all training. Coordinating and/or leading cross-functional meetings with multiple departments. Prepare product complaint investigations, assist in investigating quality issues, OOS, and OOT, and prepare reports for the same. Evaluating, developing, and qualifying manufacturing equipment (IQ, OQ, and PQ) and preparing necessary PQ protocols. Risk assessment and risk mitigation by performing FMECA (Failure modes, effects, and criticality analysis) Education Qualifications
A bachelor's or advanced degree in pharmaceutical sciences, chemistry, or a related field is typically required.
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Document Specialist/Operations Investigator
in a pharmaceutical environment Responsibilities
Investigation of manufacturing and packaging deviations and non-conformances to determine root cause and implementation of Corrective and Preventative Actions (CAPAs) to prevent recurrence. Work with cross-functional teams to gather data, lead, and perform Root Cause Analysis to determine the likely root cause of the event. Preparing investigation reports that include recommendations on investigation findings for medium/high severity non-conformances and communicating findings and recommendations at group meetings. Ability to conduct in-depth interviews and gather pertinent information to drive root cause conclusions, product impact analyses, and initiations of CAPA actions. Reviewing completed Batch manufacturing Records (BMR) and logbooks following cGMP standards in support of investigations. Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) following cGMP standards to ensure compliance with written procedures. Monitoring production processes to acquire vital data in support of investigations and track the efficiency of changes. Gathering, trending, and analyzing process-related data to drive consistency and timeliness. Training new employees in investigative processes and techniques and documenting all training. Coordinating and/or leading cross-functional meetings with multiple departments. Prepare product complaint investigations, assist in investigating quality issues, OOS, and OOT, and prepare reports for the same. Evaluating, developing, and qualifying manufacturing equipment (IQ, OQ, and PQ) and preparing necessary PQ protocols. Risk assessment and risk mitigation by performing FMECA (Failure modes, effects, and criticality analysis) Education Qualifications
A bachelor's or advanced degree in pharmaceutical sciences, chemistry, or a related field is typically required.
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