Deviation Investigator

Job Description

Job Summary:

• A leading pharmaceutical organization is seeking a Deviation Specialist to support its quality and compliance operations within a high-volume sterile manufacturing facility.
• This role focuses on conducting thorough investigations, driving root cause analysis, and contributing to continuous improvement initiatives in a regulated environment.
• This role ensures that all deviations are managed in compliance with company policies and industry regulations, and that corrective and preventive actions (CAPAs) are implemented effectively.
• The ideal candidate will be a skilled technical writer with strong communication and problem-solving abilities, and a comfort level in navigating complex production environments.

Key Responsibilities:

Deviation Management:

• 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).

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.

Qualifications:

• Regulated Industry, cGMP environment experience, deviation management, or a e.g., Pharmaceuticals, Manufacturing, Engineering, Medical, Law Enforcement, etc.].
• 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.