Senior Quality Assurance Specialist - Consultant
J
JobgetherPharmaceuticals, healthcare
Based in CanadaFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- At least 5 years of professional experience in Quality Assurance.
- Required Skills
- GCPMicrosoft OfficeQuality Assurance
Requirements
- Hold a bachelor's degree in a pharmaceutical or healthcare-related discipline, such as Chemistry, Biology, Microbiology, Pharmacy, or Pharmacology.
- Have at least 5 years of professional experience in Quality Assurance.
- Know the Food and Drugs Act, Health Canada GMP regulations, and related regulatory guidelines.
- Understand Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and data integrity principles.
- Have experience managing deviations, conducting root cause analyses, and implementing Corrective and Preventive Actions (CAPA).
- Be able to prioritize, coordinate, and complete multiple projects within established deadlines.
- Demonstrate problem-solving, attention to detail, data analysis, communication, workload management, and organizational skills.
- Work independently under general guidance and collaborate effectively with cross-functional teams and stakeholders.
- Use Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat proficiently.
- Be able to become proficient in eQMS, EMS, WMS, CRM tools, and other electronic business systems.
- Be familiar with Quality Management Systems (QMS) and standard quality documentation processes.
- Travel up to 20% may be required.
- Regulatory Affairs or Quality Assurance certification is an asset; ASQ Certified Quality Auditor (CQA), ISO 9001 Lead Auditor (QMS), or equivalent certification is preferred.
- Vendor audit experience is an advantage; experience hosting or co-hosting client audits and working in an operations environment is preferred.
Responsibilities
- Support maintenance of importer Drug Establishment Licences (DELs), Medical Device Establishment Licences (MDELs), Site Licences (SLs), and other applicable establishment licences.
- Coordinate approval of international manufacturing and supplier sites across multiple clients.
- Liaise with clients and foreign sites to obtain, review, and update master documentation for GMP compliance and product release.
- Coordinate release of commercial drug products, medical devices, natural health products, and clinical trial supplies for the Canadian market.
- Review product release documentation, including manufacturing and packaging records, Certificates of Analysis, and Certificates of Manufacture.
- Maintain and review quality documentation, including SOPs, APQRs, stability reports, qualification and validation records, artwork, and temperature studies.
- Manage deviation investigations, product quality complaints, and change control requests, including reporting and trend analysis.
- Support quality performance indicator reporting, client-specific reports, and the development and implementation of quality policies and procedures.
- Maintain document management and retrieval systems for client, international-site, and Health Canada records.
- Support audits, inspections, product recalls, mock recalls, and cross-functional quality improvement activities.
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