Medix
Deviation Investigator Consultant - 235336
Medix, Austin, Texas, us, 73301
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 requiredMinimum of 3 years’ experience in Quality, Manufacturing, Engineering, or functions or any combination of the above.CQA or CQE preferredPreferred experience in one or more of the following areas: Validation principles Pharmaceutical manufacturing methods; Documentation systems, Quality Systems; analytical or microbiological testing principles.
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 requiredMinimum of 3 years’ experience in Quality, Manufacturing, Engineering, or functions or any combination of the above.CQA or CQE preferredPreferred experience in one or more of the following areas: Validation principles Pharmaceutical manufacturing methods; Documentation systems, Quality Systems; analytical or microbiological testing principles.