Senior Quality Assurance Specialist - Consultant

Value Apothecaries; Canada; On-site; CAD 90,000 - 120,000; Full time

Job summary

Cencora in Canada is seeking a Quality Assurance professional to support regulatory compliance, documentation management and product release activities for Innomar Strategies. The role includes leading QA processes, maintaining DELs, and coordinating with clients and foreign sites to ensure GMP compliance.

You will review manufacturing records, support KPIs, and manage deviations, CAPA, PQCs and CCRs while collaborating with cross‑functional teams and responding to audits and recalls as required.

Qualifications

• Bachelor's degree in a pharmaceutical or healthcare related field.
• Minimum 5 years' experience in Quality Assurance.
• Regulatory Affairs Certification is an asset.
• Experience in conducting vendor audits is an asset.
• Experience hosting client audits is an asset.
• Experience in Operations is an asset.

Responsibilities

• Maintain DELs and approve foreign site master documents for GMP compliance.
• Review and update release documents including Certificates of Analysis/Manufacture.
• Support QA policies, KPIs and audits; lead when required.
• Manage deviations, CAPA, PQCs, CCRs and related trend analyses.
• Coordinate audits with clients and regulatory bodies as needed.
• Assist Health Canada documentation retention and recalls/mock recalls.

Skills

GMP knowledge

Regulatory affairs knowledge (GCP/GMP

Deviations & CAPA

Data analysis

Attention to detail

Communication skills

Teamwork / collaboration

MS Office proficiency

Vendor audits

Problem solving

Education

Bachelor's in pharma/healthcare

Tools

eQMS

EMS

WMS

CRM

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Job Details

This role is in support of Cencora's patient and provider support and pharma commercialization services in Canada marketed through our Innomar Strategies business.

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.

Education

Bachelor's degree in a pharmaceutical or healthcare related field (e.g. chemistry, biology, microbiology, pharmacy, and pharmacology).

Work Experience

• 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.

Skills & Knowledge

• 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.
• Knowledge of GCP, GMP, and GDP regulations and data