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