Carmen is a dedicated, flexible professional with excellent organizational and problem-solving skills supported by 17 years of pharmaceutical experience. She has a strong working knowledge of GMPs, cGMPs, and related regulations. Carmen works successfully in a team-based environment; as well, she demonstrates the ability to work independently on large projects.

Quality Control Officer (QCO)

• Oversaw all aspects of the Quality Control function for a large Canadian pharmaceutical contract support company
• Reviewed master production, packaging, deviation, raw material, and stability reports and finished product data; assessed whether product met regulatory requirements prior to release in Canada
• Worked with clients to revise and complete documentation in order to facilitate speedy release of product
• Prepared submissions to Health Canada for drugs, natural health products, medical devices, establishment licenses, and other associated annual correspondence.

Quality Assurance

• Developed program to track Laboratory Out of Specification Investigation Reports; used tracked data to prepare monthly trend analysis reports, which were used during Health Canada and FDA inspections
• Worked with Canadian and U.S. management staff to develop a transition plan for outsourcing Chemistry Lab Analysis to a company’s corporate head office
• Coordinated and performed laboratory site certification studies of new products and methods for Canadian pharmaceutical manufacturer
• Performed stability analyses to support ongoing shelf life studies.

• Hosted Health Canada inspections for numerous clients
• Prepared responses to Health Canada audit comments.

• Performed employee training on standard operating procedures (SOPs).

• Developed and updated policies, GMP SOPs, and ISO quality system procedures to meet FDA and HPFBI requirements.

• Reviewed new product technical files to determine validation and transfer criteria need to meet current regulatory guidelines
• Performed method validation, process validation, and transfers of new products.

• Oversaw a self-inspection program to meet ISO 9002 requirements
• Prepared and presented internal self-inspection audits to management staff and tracked closure of action items
• Drafted company quality manual and trained staff in relevant procedures
• Hosted registrar audits.

• Bachelor of Science – Applied Chemistry and Biology, Ryerson Polytechnical University, Toronto, Ontario

• Advanced GMP Auditing
• Audit Skills
• Deviations and Change Control
• GMP for Wholesalers, Q&C
• GMP Training
• Guidance Workshops for Product Licences and Site Licences (NHPD)
• HPFBI Audit Management
• Industrial Drug Legislation (Seneca College)
• Introduction to NHPD (NHPD)
• ISO 13485 Essentials Course
• ISO 9001:2000 Management Overview (PIC)
• ISO 9002:1994
• OOS/Deviation Reporting (Globepharm)
• Technical Writing Course, Q&C