Deviation Investigator

Job Description

Job Summary:

• Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines.
• Conduct thorough investigations to determine the root cause of deviations.
• Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs).

Duties and Responsibilities:

Documentation and Reporting:

• Maintain accurate and detailed records of all deviations, investigations, and CAPAs.
• Prepare and present deviation reports to management and regulatory authorities as required.
• Ensure documentation is completed in accordance with Good Documentation Practices (GDP).

Compliance and Quality Assurance:

• Ensure all deviations are managed in compliance with company policies, industry standards, and regulatory requirements.
• Participate in internal and external audits and inspections, providing necessary documentation and information related to deviations.

Continuous Improvement:

• Analyze deviation trends and provide insights for continuous improvement initiatives.
• Participate in training programs to enhance knowledge and skills related to deviation management and quality assurance.

Education, Experience, Certification/ Licenses:

• Associate or bachelor’s degree in a relevant field such as Life Sciences, Engineering, Medial, or Quality Management with 2+ years of related experience.
• Biologics, Aseptic, Filling Isolators, Six Sigma Certification, Electronic documentation systems.
  Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Regulated Industry, cGMP environment experience, deviation management, or a e.g., Pharmaceuticals, Manufacturing, Engineering, Medical, Law Enforcement, etc.].

Knowledge, Skills, and Abilities:

• Strong Attention to details, technical writing, Analytical and problem-solving skills.
• Knowledge of regulatory requirements and standards.
• Intermediate to Advanced skills in Microsoft Suite (Word, Excel, PowerPoint)
• Excellent communication and interpersonal skills.