Regulatory Affairs Analyst

7 months ago

Calgary, Canada Alberta Veterinary Laboratories Ltd Full time

**WE’RE HIRING**

**OUR MISSION**

At Alberta Veterinary Laboratories/Solvet (‘AVL/Solvet’), our multi-faceted team is dedicated to promoting the health and welfare of animals. Built on the values of **INNOVATION**, **QUALITY**, **PEOPLE/ANIMALS**, **ACCOUNTABILITY**, **PASSION**, and **SAFETY**, AVL is a Canadian company searching for new solutions to old problems through the development and world-wide distribution of products that bring great comfort and ease to both owners and animals. Founded in 2009, this Calgary-based, family owned and operated company has provided quality animal health products to thousands of farmers, vets, and pet owners. At AVL/Solvet our mission is simplewe listen to our customers and deliver solutions to problems they face daily.

Let’s help you launch your career with AVL/Solvet We are looking for an experienced and energetic new team member to join our **Regulatory Affairs** team **on-site** in our Calgary head office as **Regulatory Affairs Analyst**.

**THE ROLE**

Under the direction of the Regulatory Affairs Manager, the RA Analyst is responsible for participating in regulatory activities for AVL/Solvet. The RA Manager may request participation in activities related to Quality and Production associated with, but not limited to equipment, instruments, sanitation and processes required for production and testing of pharmaceutical drug products under GMP. The RA Analyst will participate in OOS, Deviation and CAPA investigations and validations as required.

**DAY-TO-DAY**
- Responsible for implementing and maintaining quality management system in a Health Canada-certified GMP (Good Manufacturing Practice) pharmaceutical facility
- Thorough understanding and implementation of with the ability to review and modify SOP’s addressing sanitation, pest control, document control, preventative-centered quality assurance, results-based quality control, material management, product recall and production practices, etc.
- Preparation of regulatory documents for Health Canada, FDA and other regulatory agencies in collaboration with Regulatory Affairs Manager
- Review and participate in preparation of drafts of validation protocols and stability studies protocols, as requested by Validation Manager
- Initiate and monitor stability program for finished drug products and APIs
- In collaboration with Quality Assurance, participate in preparing Annual Product Quality Reviews (APQR)
- Participate in internal audits to ensure GMP is maintained throughout the facility, as requested
- Oversight relating to calibration and preventive maintenance of instruments and equipment (QC laboratory, scales for production)
- Participate in incident investigations including initiation, root cause analysis, corrective and preventative actions, and effectiveness follow-up
- Prepare Change Control to track progress and resolve product issues
- Evaluate data generated for analysis and data logging
- Review of records and logbooks and follow-up, if required
- Perform other duties as requested by Senior Management

**IDEAL FIT**

Education & Experience
- Minimum of a BSc with a major in Chemistry or Biochemistry (completion of critical coursework to be verified)
- Minimum of 3-years of related work experience in Quality Control and/or Quality Assurance
- Demonstrated understanding of and able to implement Good Manufacturing Practices (cGMP) and guidelines related to the pharmaceutical industry
- Understands the content and implementation of Policies, SOPs, Work Instructions, and other technical documents
- Up to date with current trends in the pharmaceutical industry, international pharmacopoeia and ICH, as well as Health Canada regulations
- Experience working with various with computer programs, instrument software programs (i.e., Empower), databases and electronic data records

Skills and Attributes
- Excellent interpersonal and communication skills (both written and spoken) (professional level of English required)
- Reliable, punctual and thrives as part of a busy team
- Highly detail-oriented, hands-on, resourceful, and proactive in preventing and solving problems
- Proven organizational and time-management skills with the ability to prioritize to meet deadlines
- Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes
- Curiosity driven with the motivation and ability to troubleshoot processes and solve problems
- Able to work both independently with mínimal oversight and as an integral part of the team
- Comfortable with multi-tasking and adaptable to effectively manage changing priorities
- Consistently demonstrates initiative and willingness to go above and beyond
- Able to remain calm under pressure

**WHAT’S IN IT FOR YOU**

At AVL/Solvet, we are committed to keeping our team healthy and motivated, so they can do the best work of their lives. We’ve built a company where people love to come to work, and we think you will too AVL/Solvet te

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