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Regulatory Compliance Engineer Resume

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Parsippany, NJ

SUMMARY

  • Self motivated, self starter with the ability to prioritize and multi - task in a fast paced environment
  • Extensive management skills
  • Excellent written and verbal communication skills
  • Expertise in the Pharmaceutical and Medical Device industries
  • In depth knowledge of FDA Regulations, particularly 210, 211, 820, and 21 CFR Part 11
  • Working knowledge of ISO, SOX, DEA, DOT, EPA, HIPAA Standards, particularly ISO 9000 and 13485
  • Provide regulatory and compliance guidance and expertise
  • Review project deliverables for accuracy, consistency, clarity, and completeness
  • Author documentation in accordance with FDA cGXP and Electronic Records and Signatures (Part 11) regulations

PROFESSIONAL EXPERIENCE

Confidential, Parsippany, NJ

Regulatory Compliance Engineer

Responsibilities:

  • Ensure compliance with FDA regulations and ISO standards as implemented at Confidential
  • Develop and keep current validation plans, procedures, and templates
  • Ensure compliance and adequacy of system specifications and documentation
  • Act as a liaison to IT and other Business Units
  • Conduct training to validation and support personnel
  • Assists in deviation resolution as a validation and regulatory professional
  • Ensures compliance with document and record keeping requirements
  • Interfaces with Senior Management to initiate Corrective and Preventative Actions to improve the validation systems and/or to escalate quality issues uncovered during validation
  • Coordinate, review, and approve software changes (change control)

Sr. Regulatory/Compliance Computer Validation Consultant

Confidential

Responsibilities:

  • Promote consistent interpretation and application of government regulations and use of corporate policies yielding compliant, validated systems and processes
  • Provide regulatory and compliance guidance and expertise
  • Review and approve computer system validation deliverables for accuracy, consistency, clarity, and completeness
  • Perform baseline inventory, gap analysis, contingency factor assessment, and risk assessment on systems and processes
  • Author, execute, and summarize validation plans, protocols, deviation reports, and final reports in accordance with FDA cGXP and Electronic Records and Signatures (Part 11) regulations
  • Trained and managed personnel with various skills and knowledge, but not limited to validation experience, in preparing and executing validation protocols, summary reports, and qualification documents
  • Providing computer validation training to staff
  • Proactively identify, evaluate, and resolve compliance issues
  • Participate in process improvement and harmonization efforts

Quality Assurance Manager Consultant

Confidential

Responsibilities:

  • Ensured projects have appropriate testing support and resources in the correct timeframes
  • Coached and mentor testers
  • Implemented Quality Assurance best practices
  • Developed test cases and scripts, logging tests, and tracking results, reporting status
  • Experienced in running regression, system, performance and User Acceptance Testing (UAT) testing
  • Developing and documenting business requirements related to Change Control requests
  • Prioritizing and scheduling all Change Control requests for deployment
  • Coordinate production code release with development and release management teams
  • Manage and be accountable for QA and UAT phases relating to said Change Control requests
  • Manage all facets of deployment associated with Change Control requests including updating Training Materials as required and communicating enhancements to all application stakeholders
  • Coordinate production code release with development and release management teams.

Confidential

Computer Validation Technical Specialist

Responsibilities:

  • Cultivated the Validation Department within Corporate IS.
  • Managed and executed validations of Computerized Systems for Pharmaceutical Laboratory, Shop Floor, Manufacturing, Distribution, Mathematical, Business and Informational systems including Validation Plans, Protocols, and Final Reports.
  • Trained colleagues and consultants in Validation practices and techniques and Quality Assurance and Quality Control principles, Auditing, Testing strategies and Vendor auditing
  • Performed Quality Assurance Practices by facilitating generation of departmental standards, procedures, disaster recovery plans and security requirements
  • Performed Quality Control Practices by reviewing Functional Requirements, System Specifications, Program Code, Test Plans and Results, and JCL for adherence to standards and accuracy
  • Presented to and trained large groups of colleagues (30 or more people).
  • Installed and maintained Quality Assurance Software
  • Supported International Sales, International Profit and Loss, International Legal Entity, General Ledger, and AMAPS
  • Designed, developed, and demonstrated a pilot front end system written in Easel, running under DOS

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