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Compliance Investigator

Posted 21 days ago

  • Sector: Scientific
  • Contact: Michael Menzer
  • Contact Email:
  • Contact Phone: 7323534231
  • Start Date: 02/22/2021
  • Expiry Date: 13 March 2021
  • Job Ref: 21-02776

Job Summary
The compliance investigator is responsible for investigating handling reporting and documentation of deviations nonconformances and complaints in the operations department Interact and effectively communicate with subject matter experts SME from all departments to determine root cause and appropriate CAPA Support Compliance and Quality Assurance management in maintaining and improving cGMP quality Systems Investigator will assist Qualification Engineer with the development and review of protocolsreports related to the ITManufacturing department The Compliance Investigator will directly report to the Director of Operations and will assist throughout the manufacturing documentation when necessary

Reporting Relationships
bull This person is expected to work under minimal supervision Work is reviewed upon completion for adequacy in meeting objectives This position has no direct reports
Essential Functions
bull Initiate deviations complaints investigations as and when they are notified
bull Perform Root Cause Analysis RCA investigations and impactrisk assessments in response to deviations OOS results nonconforming events and Customer Complaints
bull As part of each investigation gather information from all necessary internal and external sources in order to find the root cause and to evaluate the impact of the deviation on manufactured product as well as the risk to previous productsfuture operations
bull The investigator will conduct and drive nonconformance eventsdeviations to identify root cause product impact and preventative actions for Manufacturing Operations in support of batch disposition and continuous process improvement Work with internal teams to obtain an indepth understanding of the product and the documentation requirements
bull Work across functions with a professional manner to conduct investigations and works independently to comply with procedure driven guidelines relating to deviation investigations
bull Produce highquality investigation documentation that meets applicable standards and is appropriate for its intended audience bull Properly assess the manufacturing or analytical environment and independently conceives and initiates appropriate correctivepreventative actions CAPAs designed to mitigate Quality deficiencies identified in the investigative process using analytical tools
bull Conduct training to employees based on the deviationsCAPAs
bull Track the progress of the open CAPAs and ensure closure of the CAPAs in timely manner
bull Provides technical assistance to area supervisors or managers to solve complex problems Exercises judgment in developing practices techniques and evaluation criteria for obtaining results
bull Prepare monthly quarterly and annual investigationsCAPAs trend reports
bull Client and report any trends in reported deviationsinvestigations
bull Conduct training to employees based on the deviationsCAPAs
bull Authors and reviews Protocols and subsequently develops protocol reports to support manufacturingpackaging events deviationsCAPA39sOOS
bull Initiate change controls for manufacturing related operations Author departmental Standard Operating Procedures SOPs Protocols technical reports etc
bull Assist QualificationCVS Engineer with development review and execution of protocolsreports and other qualification documents related to ITManufacturing department
bull Assist Compliance management with the development and implementation of continuous quality improvement plans
bull Support Compliance and Quality Assurance in maintaining and improving cGMP quality Systems
bull Perform quality system audits to ensure compliance with company SOPs and cGMPs
bull Generate trend reports for investigation nonconforming events and CAPAs Client and report any trends
bull Other duties as assigned

Specialized Skills and Knowledge
bull EducationCertifications
o BABS Degree in science field eg Biology Microbiology Chemistry Pharmacy etc or equivalent combination of education and experience 35 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including Manufacturing Validation and Process engineering
o Pharmaceutical or related FDA work experience strongly preferred
bull Must know the operation of pharmaceutical production equipment
bull Experience in solid dosage manufacturing process and quality
bull Demonstrates strong analytical and technical skills
bull Ability to articulate discuss and glean information from Manufacturing QC QA RA and engineering personnel to write a complete investigation
bull Excellent verbal communication and strong written English skills with a proven record of producing technical reports in a clear and concise manner
bull Strong experience and comprehension of MS Office programs mdash primarily MS Word and excel
bull Experience in statistical process control is a plus
bull Assures compliance to all procedures and policies concerning all areas of manufacturing logistics safety and human resources
bull Must be able to work in fast paced environment
bull Previous technical writing experience required
bull Other duties as assigned

Key Competencies
1 Critical thinking and Problem solving
2 Writing and research skills
3 Attention to detail