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Contract: Quality Assurance Deviations Writer and Investigator

Bulletproof Documentation, Inc.

Location:
Burlingame, Korea (South)
Posted Date:
7/7/2014
Position Type:
Consultant, Contract, Full time
Job Code:
14
Salary:
Required Education:
High school or equivalent
Areas of Expertise Desired:
Cell Culture, Manufacturing, Purification, Quality Assurance,

Job Description

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
•   Provide general quality assurance and documentation support as requested

Requirements

•   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.  No remote work.

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