Cambrian Healthcare Consulting Inc.

Professional consulting and implementation services for Quality Management Systems, Validation, and Temperature Controlled Transportation serving the Pharmaceutical, Biotech, and Logistics industries. Specialized in eQMS implementations.

Principal Consultant

SKILLPAD

Lead Consultant, Compliance

Accuristix

Validation Manager

Taro Canada

Computer Validation Specialist

Apotex Inc.

CSV Consultant

Nycomed Canada

Developed requirements documentation, performed functional risk assessments, created test plans, test protocols, and test scripts. Contributed to and consulted for local and global Quality teams, North American lead for infrastructure qualification. Designed and implemented local governance procedures and introduced business analysis best practices to the business units. Trained and coached peers in Quality System principles, Validation methods, and local IT governance procedures.

IT  Business Analyst / Quality Assurance

Invensys

Provided regulatory and systems validation consulting services across Canada and in the United States. Performed compliance risk assessment and gap analysis audits, designed and implemented mitigation strategies for customers, authored proposals, project plans, and developed validation documentation based on the GAMP (SDLC methodology). Performed post-implementation and periodic reviews.

Sr. Computer Systems Validation Specialist

Eli Lilly Canada

Responsible for quality inspection and release of incoming materials, performed printed packaging review, liaised with vendors, managed bulk and finished goods release for dry products, including batch ticket review. Participated in MRPII system upgrade project for BPCS developing functions and processes for QA, including validation testing. Consulted with business as Subject Matter Expert for BPCS Shop Floor Control and Inventory Control modules, and contributed expertise in Y2K upgrade project for the MRPII and related systems.

Quality Control Associate

The Griffith Laboratories

Spice & Cereal Tech

Seasoned professional providing Business Analysis, Validation, and Quality Assurance services to the pharmaceutical, medical devices, blood, and Third Party Logistics industries for 30+ years.

Expertise in delivering solutions to your business problems in the areas of:
-Validation of Computerized Systems, Facilities, Equipment, Transportation Systems
-IT Governance & Quality Risk Mitigation
-Regulatory Quality and Compliance (Pharma) including Risk Analysis and Management strategies
-Enterprise Analysis / Business Analysis & Project Management
-Audit Defense and Compliance Auditing
-Periodic Review and Data Integrity Gap Assessment
-Integration of Validation with Quality Management Systems

Specialized expertise in: Computer Systems Validation, eQMS implementations, and application of GUI-0069 Guidelines for environmental control of drugs during storage and transportation , USP <1079> Good Storage and Shipping Practices, and USP <1083> Good Distribution Practices—Supply Chain Integrity.

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