Deirdre Grixti is a congenial team leader with 15 years QC laboratory and QA experience. A creative problem solver, she is able to conceive, develop, and implement new strategies and processes that improve quality and efficiency. In addition, she is both a dynamic leader and a committed team builder, prioritizing effectively while respecting the priorities of others.

Ms. Grixti communicates easily and openly with people at all levels of the industry. Proficient in GMPs in Canada and the United States, she is also knowledgeable in analytical laboratory procedures involving wet chemistry analysis, and in chemical assays using instruments such as HPLC, GC, IR, UV, and Dissolution. Deirdre's excellent project management skills are complemented by her ability to work with the client in utilizing their systems and their personnel to complete the project.

• Developed a plan for transitioning a Research & Development drug product development site to a GMP facility; served as Quality Assurance during transition.
• Managed a large validation implementation within a tight time frame of three weeks to meet a regulatory deadline.
• Identified gaps in various quality systems, developed full quality plan for each to implement GMPs; overseeing completion of each plan.
• Performing full range of on-site quality control activities and regulatory activities for independently owned Private Label manufacturer of OTC, prescription, narcotics, and herbal products.
• Providing ongoing QA services and performing GMP compliance activities for a biopharmaceutical company.
• Organized, reviewed and verified stability data for Research & Development department; prepared detailed stability reports.
• Evaluated and restructured master document filing systems for a multinational brand-name consumer products manufacturer. Created an index of the documents required for each product and performed a gap analysis.
• Performed quality control/assurance gap analysis of process systems and documentation for a pharmaceutical company involved in clinical trials. Worked with client to develop and implement processes and documentation addressing identified gaps.
• Established, implemented, and maintained the following systems for a pilot plant: SOPs, Deviations, Change Control, Returns, Recalls, Complaints, Self-Inspection, Preventive Maintenance, Calibration, and Validation.
• Implemented protocol for a Historical Data Analysis producing 90 final reports.

Technical Writing

• Coordinated the development, writing, review, and approval of Standard Operating Procedures (SOPs) for a pilot plant (Facilities, Manufacturing, Laboratory, Shipping and Receiving, and Quality Assurance), ensuring that all complied with GMP and cGMP requirements.
• Wrote Site Reference Files for a major pharmaceutical manufacturer’s main packaging, warehousing, fabrication, and distribution facilities.
• Coordinated the drafting and revision of 40 SOPs for a smaller, innovative pharmaceutical manufacturer in a time span of seven weeks. Ensured that these SOPs met end-user needs while complying with GMP and cGMP standards for Canada and the United States.

cGMP Auditing and Training

• Coordinated successful completion of a series of eight international supplier audits to a client's corporate standards in a 3-week period.
• Coordinated and executed self–inspection program for a major pharmaceutical company.
• Performed GMP audit for an importer.
• Delivered a major pharmaceutical company's GMP training course for six months.
• Provided weekly coaching to plant staff in the implementation of their GMP Quality Systems, achieving an HPFBI compliant rating within 3 months.

• Honours Bachelor of Science, Chemistry, University of Western Ontario, London, Ontario, 1986
• Post Graduate Courses: Protein Biosynthesis, Lipids, 1987

• Advanced GMP Auditing
• Advanced GMPs and Current Inspection Trends, PSG
• Advanced Instructional Techniques, Langevin
• Auditing Skills
• cGMP Overview, Aventis Pasteur
• Clinical Trial Overview/ Introduction to Clinical Quality Assurance
• Delegation Workshop/Thinc Strategies (Thinc)
• Deviations and Change Control, Q&C
• Fundamentals of Regulatory Affairs, CanReg Inc.
• GMP for Importers/Distributors, Q&C
• GMP Interpretation and Application, Pharmanet
• GMP Manufacture of Drugs Used in Clinical Trials
• GMP Training, Aventis Pasteur
• HPFBI Audit Management
• Industrial Drug Legislation, Seneca College
• ISO 9001:2000 Overview, Q&C
• Legal Issues in the Pharmaceutical Industry, PSG
• Mechanics of Preparing INDs and NDAs and FDA Regulations, Centre for Professional Advancement
• Pharmaceutical Label Review, CanReg Inc.
• Product Disposition, Q&C
• Project Management, Kepner-Tregoe
• SOP Writing
• Technical Writing Course, Q&C