Title: Deviation Writer
Duration: 12 Months
Location: Morris Plains, NJ - 07950
Onsite role in Morris Plains, NJ
Description:
To author deviations related to facilities and engineering processes, equipment and areas. This includes the initiation, investigation, authoring, identifying correct CAPAs and effectiveness checks of those CAPA's and throughout meeting required timelines.
Major Accountabilities:
Deviations, Investigations, and CAPAs:
• Initiate deviations within required timelines.
• Support the facilities team in the triage of unexpected events.
• Author investigations for facilities and engineering related deviations within required timelines.
• Work cross-functionally to assess deviation impact and identify root causes.
• Use equipment/facility knowledge and root cause investigation tools to analyze data and to identify root
causes.
• Work collaboratively in the design CAPAs and CAPA effectiveness checks to eliminate/mitigate deviations.
• Support the process of escalation of deviations when appropriate according to escalation guidelines. Present
escalation events and provide deviations details clearly and on-time (root cause and CAPAs).
• Provides support for all internal or external audits.
Key Performance Indicators:
• Opening, and closing of deviations within required timeframes
• Closing of CAPAs within required timeframe
• Effectiveness of CAPAs
• Success rate of internal audits and Health Authorities' inspections
Requirements:
Education: BSc. in Engineering or equivalent scientific degree.
Languages: Fluent in speaking / writing in English
Experience: Minimum 3 years' experience in GMP manufacturing role with 1 year of deviation/root cause analysis experience.
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