Regulatory Compliance Specialist

6 days ago

Somerset, United States The Staffing Resource Group Inc Full time
Job Description

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services.

Our innovative approach to identifying and qualifying talent is unique to the staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements.

We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Key Responsibilities:
  • Manage the supplier quality program and ensure Supplier Quality Management deliverables are met as required.
  • Facilitate and host customer audits at the site to ensure compliance with cGMPs, as well as Corporate and site standard operating procedures.
  • Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health authority regulations.
  • Lead the activities for preparing an oral solid dose manufacturing site for inspections by US FDA and applicable foreign regulatory authorities.
  • Participate in all aspects of inspections from initiation, preparation, execution through closure.
  • Lead the internal audit program at the site.
  • Assist the site in preparing written responses to address the observations for customer audits, internal audits, corporate audits, and regulatory inspections.
  • Ensure responses are completed as committed.
  • Inform QA management where resolution of audit findings is inadequate or when audit commitments are not met.
  • Initiate deviations when site procedures are not followed.
  • Assist in preparing for PAI audits for new product approvals at site, compiling documents and reviewing to ensuring audit readiness.
  • Participate in the preparation of Supplier and Customer Quality Agreements.
  • Participate in global supplier and regulatory meetings and effectively represent the site.
  • Review and approve TrackWise Records as needed acting as a QA Representative.
  • Review and revise departmental SOPs as required.

Requirements:
  • A bachelor's degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function.
  • Associate degree or High School Diploma with 10+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function.
  • Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field is required.
  • Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities is required.
  • Understanding of various audit types (e.g. Customer, Supplier, Agency etc.) and techniques (e.g. Onsite, Questionnaire etc.) is preferred.
  • TrackWise experience is preferred.
  • ASQ CQA or relevant Certification is highly preferred.

EOE/ADA

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