Contact Information

T: 905.363.1182 x.227
F: 905.542.7981

TF: 1.877.877.5152 x.227
M: 416.277.5218

2550 Argentia Road • Suite 119 • Mississauga ON • L5N 5R1
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VP, Quality Services

Carmen is a dedicated, flexible professional with excellent organizational and problem-solving skills supported by over 20 years of pharmaceutical experience. She has expertise in Good Manufacturing Practices (GMPs), Current GMP (cGMPs), and related regulations. She applies a risk-based approach to implementing regulations, providing thoughtful justification for recommendations/decisions. Carmen works successfully in a team-based environment and also works well independently. She has strong people management skills as well as leadership skills.

Skills and Highlights

Project Management

  • Manages multiple roles and priorities within Q&C
  • Coordinates completion of numerous continuous improvement projects to help organization grow
  • Cognizant of maintaining confidentiality.
  • Provides detailed explanations of processes, regulations, or concepts
  • Uses good listening skills to understand another’s position and confirm translation
  • Set up and implemented quality assurance systems for importers and distributors
  • Identified gaps in various quality systems, developed full quality plan for each to implement GMPs; overseeing completion of each plan
  • Trained in project management principles

Quality Control Officer (QCO)

  • Oversaw all aspects of the Quality Control function for a large Canadian pharmaceutical contract support company
  • Reviewed master manufacturing, packaging, labelling, deviations, raw material, and stability reports and finished product data to assess 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
  • Recall: Handled drug, NHP recalls
  • Initiated, investigated, and determined corrective and preventative actions for deviations and non-conformances

Quality Assurance

  • Providing ongoing QA services and performing GMP compliance activities for a biopharmaceutical company
  • Initiated, determined actions and closed actions for change controls related to all aspects of 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
  • Prepared Quality Assurance Report (QAR) for NHPD
  • 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
  • Submitted Annual Drug Notification

Auditing

  • Hosted Health Canada inspections for numerous clients (GMP, GVP, and medical devices)
  • Prepared responses to Health Canada audit comments
  • Audited foreign active pharmaceutical ingredient (API) manufacturing, packaging, and testing facility against Health Canada Drug GMPs, NHPD GMPs, and FDA cGMPs

Regulatory

  • Filed Drug Establishment Licences (DEL), DEL amendments, Site Licence applications and category IV Drug Identification Number (DIN) submissions
  • Filed Natural Health Product Directorate (NHPD) product licence application (compendial, non-compendial, traditional) amendments and notification to Product Licence Application (PLA)
  • Prepared submissions to Health Canada for drugs, natural health products, medical devices, establishment licenses, and other associated annual correspondence
  • Performed product label review for regulatory compliance (drug, cosmetic, Natural Health Product [NHP])

GMP Training

  • Developed and delivered GMP Fundamentals course for pharmaceutical and NHP clients
  • Performed employee training on Standard Operating Procedures (SOPs)

Technical Writing

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

Validation

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

ISO Compliance

  • 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

Medical Devices

  • Filed medical device licencing for class I and II devices
  • Classified medical devices
  • Managed Medical Device Establishment Licences (MDEL) and amendments to MDEL
  • Hosted Health Canada medical device importer/distributor audit
  • Handled medical device customer complaints and adverse events

Computer Skills

  • Microsoft Office – Word, Excel, PowerPoint, Access

Education

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

CONTINUING EDUCATION, CAREER DEVELOPMENT

  • Advanced GMP Auditing
  • Auditing Skills
  • Biologics – Health Canada workshop on Lot Release Program
  • Deviations and Change Control
  • Fundamentals of Regulatory Affairs
  • GMP for Wholesalers
  • GMP Training
  • Guidance Workshops for Product Licences and Site Licences
  • GVP Training
  • HPFBI Audit Management
  • Industrial Drug Legislation
  • Introduction to NHPD
  • ISO 13485 Essentials Course
  • ISO 9001:2000 Management Overview
  • ISO 9002:1994
  • OOS/Deviation Reporting
  • Technical Writing Course
  • Workplace Health & Safety