Quality Assurance Deviations Writer and Investigator

South Korea  ‐ Onsite
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Keywords

Description

Quality Assurance Deviations Writer and Investigator

Scope of Work:

As assigned by client quality management, contractor to provide quality assurance support associated with:
  • Writing deviations
  • Conducting investigations
  • Conducting root cause analysis
  • Identifying corrective and preventive actions (CAPAs)
  • Developing CAPA action plans
  • Writing investigations summary reports
  • Providing on-the-manufacturing-floor quality input and decision-making support
  • Writing and revising cGMP documentation, including SOPs and batch records


Contractor responsibilities are:
  • Write, review, and/or edit deviations to ensure the event is clear, concise, complete, and meets Client quality requirements. Ensure any immediate actions taken to mitigate the effect of the deviation are documented.
  • Conduct investigations thoroughly to identify all impacts to patients, product quality, validated state, and regulatory compliance.
  • Conduct root cause analysis to identify all contributing and potentially contributing factors that led to the deviation.
  • Perform risk analysis as needed to determine likelihood and severity of recurrence.
  • Develop CAPAs and CAPA action plans.
  • Write final investigation reports with focus on the following reviewers in mind:


o Client quality assurance

o Regulatory agencies

o Client customers
  • Perform all technical writing with focus on clarity, conciseness, grammatical and mechanical correctness, accuracy, and completeness. Adhere to Client document styles and templates as applicable.
  • Facilitate the investigation review and approval processes within applicable turnaround times or as needed to meet batch release timelines.
  • Comply with Client quality requirements throughout investigations process.
  • Be physically present in manufacturing areas during critical operations to:


o Facilitate real-time documentation review and good documentation practices

o Assist with determining and documenting deviations and process comments

o Assist with training manufacturing associates on quality impacts
  • Provide general quality assurance and documentation support as requested
Start date
07/2014
Duration
6 months
From
Real Staffing
Published at
12.07.2014
Project ID:
740665
Contract type
Freelance
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