Job Details Primary Duties and Responsibilities:
- Maintenance of importer Drug Establishment Licenses (DELs) and the approval process for a large number of foreign sites for multiple clients.
- Coordinate with clients and / or foreign sites for the receipt, review and updates to master documents to ensure compliance to GMPs and in relation to product release activities.
- Release of commercial drug product and / or clinical trial supply to the Canadian market for Innomar or customers as required.
- Perform timely review and assessment of documents received from clients / foreign sites, including but not limited to manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, and other product release documents.
- Assist Management in the preparation of routine key quality performance indicators (KPIs) to generate client specific report metrics, acting as a Team Lead when required.
- Maintain and review in-house and client-based quality documents, e.g. SOPs, APQR, stability reports, qualification / validation protocols and reports, artwork, temperature studies etc.
- Process Deviation investigations, including report generation and any associated trend analysis.
- Process Product Quality Complaints (PQCs), including report generation and any associated trend analysis.
- Process Change Control Requests (CCRs), including report generation and any associated trend analysis.
- Assist QA Management in the development / revision and implementation of QA policies and procedures, acting as a Team Lead when required.
- Sustain an effective system for maintaining copies of documents received from clients / foreign sites as well as those submitted to Health Canada, allowing ease of location and retrieval of records.
- Provide support during audits / inspections (i.e. internal, client, third party or regulatory agencies) as required.
- Provide support during recall / mock recall events (client and internal) as required, acting as a Team Lead when required.
- Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients.
- Participate in and support project teams and advise other departments on Quality Assurance issues and strategies, when required.
- Travel up to 20% may be required.
- Other duties, as assigned.
Experience and Educational Requirements:
- Bachelor's degree in a pharmaceutical or healthcare related field (e.g. chemistry, biology, microbiology, pharmacy, and 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.
Minimum Skills, Knowledge and Ability Requirements:
- Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations and associated guidelines.
- Demonstrated ability to effectively prioritize, coordinate and complete multiple projects within established timeframes.
- Demonstrated ability in the effective management of deviations, root cause analysis, and CAPA implementation.
- The ability to identify pragmatic solutions to compliance / operational problems and challenges.
- Strong attention to detail, proven data analysis skills and the ability to present these findings effectively.
- Ability to work both independently and in a team environment, always promoting positive, respectful and professional relationships.
- Strong proficiency in common office applications (e.g. MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, etc.) and the ability to achieve rapid fluency in business related electronic applications/platforms (e.g., eQMS, EMS, WMS, CRM, etc.).
- Excellent written and verbal communication skills.
Equal Employment Opportunity
Cencora
