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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in Quality Assurance, including regulatory compliance, deviation management, and CAPA implementation. Proficient in maintaining GMP standards and conducting audits while effectively communicating with internal and external stakeholders.
Highest-signal resume keywords
Quality Assurance ExperienceRegulatory Compliance KnowledgeDeviation ManagementGMP Regulations ExpertiseASQ Certified Quality Auditor
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Deviation ManagementRoot Cause AnalysisCAPA ImplementationQuality Performance IndicatorsGMP ComplianceVendor AuditsClient AuditsData Analysis
Soft Skills
Attention to DetailProject CoordinationProblem-SolvingTeam CollaborationCommunication Skills
Tools & Technologies
MS WordExcelPowerPointOutlookAdobe AcrobatEQMSEMSWMSCRMQuality Management Systems
Certifications & Qualifications
Regulatory Affairs CertificationASQ Certified Quality AuditorISO 9001 Lead Auditor
Industry Keywords
Food and Drugs ActHealth CanadaGMP RegulationsGCP RegulationsGDP RegulationsData Integrity Principles
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Support Cencora’s patient and provider support and pharmaceutical commercialization services in Canada through Innomar Strategies
- Support execution of quality-related tasks and activities for the Innomar QA Consultancy group
- Maintain importer Drug Establishment Licenses and approve foreign sites for multiple clients
- Coordinate with clients and foreign sites to receive, review, and update master documents for GMP compliance and product release
- Release commercial drug products and clinical trial supplies to the Canadian market
- Review manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, and other product release documents
- Prepare quality performance indicators and client-specific report metrics, acting as Team Lead when required
- Maintain and review SOPs, APQRs, stability reports, qualification and validation protocols and reports, artwork, and temperature studies
- Process deviation investigations, product quality complaints, and change control requests, including reports and trend analysis
- Assist with developing, revising, and implementing QA policies and procedures
- Maintain copies of client and foreign-site documents and submissions to Health Canada for retrieval
- Support internal, client, third-party, and regulatory audits and inspections
- Support client and internal recalls and mock recalls, acting as Team Lead when required
- Liaise with internal and external contacts, including potential clients
- Participate in project teams and advise departments on Quality Assurance issues and strategies
- Travel up to 20% may be required
Requirements
What you’ll need- Bachelor’s degree in a pharmaceutical or healthcare related field, such as chemistry, biology, microbiology, pharmacy, or pharmacology
- Minimum of 5 years’ experience in Quality Assurance
- Regulatory Affairs or Quality Assurance Certification is considered an asset
- Experience in conducting vendor audits is considered an asset
- Experience in hosting/co-hosting client audits is considered an asset
- Experience working in an Operations environment is considered an asset
- Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations, and associated guidelines
- Demonstrated ability to prioritize, coordinate, and complete multiple projects within established timeframes
- Demonstrated ability in deviation management, root cause analysis, and CAPA implementation
- Ability to identify pragmatic solutions to compliance and operational problems
- Strong attention to detail and data analysis skills
- Ability to work independently and in a team environment
- Proficiency with MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, eQMS, EMS, WMS, CRM, productivity tools, and Quality Management Systems
- Excellent written and verbal communication skills
- Knowledge of GCP, GMP, GDP regulations, and data integrity principles
- Ability to work under general guidance and prioritize workload
- Ability to identify straightforward problems and apply precedents to resolve them
- ASQ Certified Quality Auditor, ISO 9001 Lead Auditor, or equivalent preferred
Benefits
Comp & perks- Medical, dental, and vision care
- Backup dependent care
- Adoption assistance
- Infertility coverage
- Family building support
- Behavioral health solutions
- Paid parental leave
- Paid caregiver leave
- Training programs
- Professional development resources
- Mentorship programs
- Employee resource groups
- Volunteer activities
