As assigned by 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
o Provide general quality assurance and documentation support as requested
• BS/BA and at least 10 years pharmaceutical industry experience, biologics manufacturing experience mandatory.
• Impeccable attention to detail and technical understanding of pharmaceutical manufacturing and quality.
• Ability to manage shifting priorities and fast pace.
• Strong written and verbal communication skills.
• Comfortable leading and influencing without authority.
• Comfortable partnering with internal and external groups.
• Proven ability to present to senior management, address difficult questions, and defend quality-related recommendations and decisions.
• Ability to manage investigations to closure.
• Able to travel outside country for up to 3 months at a time. No remote work.