Deviation Investigator Consultant - 235336

We are looking for an individual with strong deviation investigation and CAPA experience within a GxP pharma manufacturing setting. Candidates must be local to the area.

• Likely a 4 month assignment with opportunity for extension.
• On site, M-F, Standard Business Hours.
• Pay negotiable based on experience.

Overview: You will support our client by conducting investigations into process excursions, procedural exceptions and nonconforming events while ensuring root cause, CAPA, and product impact are addressed during these investigations.

Responsibilities:

• Conduct investigations into process excursions, procedural exceptions and nonconforming events.
• Ensure root cause, corrective action preventative action (CAPA), and product impact are thoroughly addressed in investigations. Synthesize recommendation for action based on procedural requirements, decision flowcharts, and critical thinking.
• Document investigations results.
• Develop, implement, manage and track effectiveness of corrective action plans for exceptions.
• Provide training and conduct verification assessments to ensure adequate maintenance of quality systems and processes as required.
• Manage projects to ensure they are completed within the required time schedule as required per quality systems.
• Provide support activity during regulatory or 3rd party audits.
• Utilize trend data to develop schedule and incorporate into facility investigations.
• Ensure accurate investigation schedules are maintained and communicated to management.
• Deliver notifications to management.
• Adhere to all company guidelines, SOPs and ensure required compliance training is up to date.
• Monitor GMP and regulatory compliance activities critical in a regulatory inspection.
• Communicate GMP violations and quality systems deficiencies to management and recommend MQ product release holds until the violation is addressed.

Requirements:

• Bachelor’s Degree is required
• Minimum of 3 years’ experience in Quality, Manufacturing, Engineering, or functions or any combination of the above.
• CQA or CQE preferred
• Preferred experience in one or more of the following areas: Validation principles Pharmaceutical manufacturing methods; Documentation systems, Quality Systems; analytical or microbiological testing principles.