What are the responsibilities and job description for the Deviation Investigator position at TekOne IT Services Pvt. Ltd.?
Job Title: Deviation Investigator
Location: Baltimore, MD
Duration: 12 Months (Contract)
Key Responsibilities
Location: Baltimore, MD
Duration: 12 Months (Contract)
Key Responsibilities
- Review and investigate deviations, non-conformances, and other quality incidents by analyzing Master Batch Records, process validation protocols, SOPs, and other critical documents.
- Conduct root cause analysis (RCA) using appropriate tools to identify the causes of deviations, ensuring clear, detailed documentation of findings.
- Draft investigation reports, outlining root cause, corrective and preventive actions (CAPA), and necessary follow-up activities.
- Develop and recommend remediation strategies in collaboration with subject matter experts (SMEs), ensuring all corrective and preventive actions are documented and verified for effectiveness.
- Assist in the review and approval of remediation plans, including change controls related to deviation corrections.
- Ensure that all investigations, reports, and remediation activities comply with FDA regulations, ICH guidelines, and cGMP requirements.
- Regularly update and apply regulatory knowledge to the deviation management process.
- Provide deviation records and support internal and external audits by participating in audit activities and addressing audit findings.
- Ensure that all deviation-related documentation is complete, compliant, and available for audits.
- Oversee and ensure the effective implementation of CAPA plans to prevent recurrence of deviations.
- Verify the effectiveness of CAPA through follow-up assessments and performance checks.
- Identify and analyze trends in deviations, leading initiatives to improve manufacturing processes and reduce the frequency of deviations.
- Participate in continuous improvement projects focused on optimizing quality systems and enhancing process reliability.
- Provide training and guidance to team members on deviation management processes, RCA methods, and proper documentation practices.
- Ensure high standards of data integrity in the use of documentation management systems (e.g., TrackWise, Veeva, Kneat) for tracking deviations, CAPA, and associated records.
- Apply risk-based methodologies to prioritize and address critical deviations with a focus on product quality and patient safety.
- Perform other related duties as assigned by management to support compliance and continuous quality improvements across the organization.
- Bachelor’s Degree in Chemical Engineering, Biomedical Engineering, Biochemical Engineering, Biological Sciences, or a related field.
- 2-10 years of relevant industry experience working in a cGMP-regulated environment within the pharmaceutical, biotechnology, or medical device industry.
- Experience in deviation investigation, quality assurance, and remediation activities.
- Experience reviewing Master Batch Records, validation documents, and other critical documents associated with product manufacturing and process validation.
- Experience with aseptic manufacturing environments and knowledge of sterility assurance practices.
- Advanced proficiency in statistical analysis and trend analysis for monitoring deviation patterns.
