Regulatory Associate:

As a Q&C Regulatory Associate, you will develop regulatory strategies for assigned projects/products; prepare and coordinate submission of license applications to regulatory authorities or third parties; deliver or support the delivery of local or global projects from product development through to approval; provide regular reports on progress and specific issues. Activities include organization and review of documents for submission, preparation of documents and summaries as required, and editorial review of all components for regulatory applications and submissions. Additional activities include license maintenance activities and responding to Regulatory authority requests for information.

Required Qualifications:

• Minimum University degree, B. Sc. in a specific scientific field
  (Chemistry or Microbiology)
• Minimum three (3) years previous experience with Canadian regulatory affairs, including DIN submissions, drug establishment licensing, natural health product site licensing, narcotic and controlled substance regulations, natural health product licensing, medical device establishment licensing and product licensing and cosmetic regulations
• In-depth knowledge of North American and International regulations and guidelines including GMP/GLP
• Ability to negotiate priorities and licensing strategies
• Excellent project management and computer skills

	Quality Control Officer (QCO):

As a full-time quality control officer, in accordance with approved project plans you will: disposition product, including detailed review of Certificates of Analysis/Manufacture, batch documentation, etc.; assist with setup of QCO systems and/or perform ongoing QCO activities for GMP Importers/Distributors/Warehouses; assist in Quality Control role according to established procedures.

Required Qualifications:

• Bachelor of Science degree in chemistry, microbiology, biology, pharmacy, toxicology or related science, or equivalent industry experience
• Minimum 2 years in the pharmaceutical industry in a regulatory, quality assurance, or quality control role
• Excellent project management and computer skills

	Compliance Associate:

Responsibilities

Function as a full-time consulting associate for a pharmaceutical consultancy. Deliver the following services in accordance with approved project plans.

Large Compliance Project (LCP) Consulting:

• Manage/assist with large compliance projects:
  • Implementation and maintenance of quality systems for drug fabricators
  • GMP for clinical trial materials
  • Health Canada audit corrective actions
  • Backlog cleanups - stability reports, change controls, deviations,
     batch record reviews, etc.
  • Interim Quality Control services for fabricators - managing quality systems
     during client growth and/or transition

Technical writing:

• Review/revise/write SOPs, technical reports, spreadsheets, etc.
• Act as a subject matter expert for all aspects of GMP and quality assurance

GMP auditing:

• Evaluate conformance of third-party suppliers to regulatory standards (Health Canada, FDA, etc.)
• Perform self-inspections

GMP training:

• Facilitate GMP training sessions
• Train on SOPs

Expectations

The employee is expected to have the following:

• The ability to work independently and as part of a project implementation team
• Self-motivation
• Project-oriented skills, with the ability to work on more than one project at a time
• Strong organizational skills
• Excellent attention to detail
• A flexible personality style

Minimum Qualifications

Education:

• Bachelor of Science degree in chemistry, microbiology, biology, pharmacy, or related science, or post-secondary diploma and equivalent industry experience

Experience:

• Minimum 2 years in the pharmaceutical industry in a quality assurance, quality control, or laboratory role

Computer skills:

• Functional skills in Word, Excel, PowerPoint, Visio, MS Outlook
• Willingness and ability to learn new applications

	Validation Engineer:

Responsibilities

Function as a full-time consulting associate for a pharmaceutical consultancy. Deliver the following services in accordance with approved project plans.

Validation Projects:

• Perform The Validation Gap Analysis™
• Write/revise Validation Master Plans and Project Validation Plans
  • Production Equipment IQ/OQ/PQ
  • Analytical Equipment Qualification
  • Analytical Method Validation
  • Process Validation
  • Facilities and Utilities Qualification
  • Design Qualification
  • Cleaning Validation
  • Computer Validation
  • Sterilization Process Validation
• Develop and execute validation protocols
• Write final reports
• Coordinate reviews and approvals

Project management:

• Manage large compliance projects and/or develop detailed implementation plans, using The Quality Plan™ where applicable

GMP auditing:

• Evaluate conformance of third-party suppliers to regulatory standards (Health Canada, FDA, etc.)

Technical writing:

• Write/revise SOPs, instructions, technical reports, spreadsheets, etc.
• Act as a subject matter expert

Expectations

The employee is expected to have the following:

• The ability to work independently and as part of a project implementation team
• Self-motivation
• Project-oriented skills, with the ability to work on more than one project at a time
• Strong organizational skills
• Excellent attention to detail
• A flexible personality style

Minimum Qualifications

Education:

• Bachelor of Science degree in chemistry, microbiology, biology, pharmacy, or related science, or post-secondary diploma and equivalent industry experience

Computer skills:

• Functional skills in Word, Excel, PowerPoint, Visio, MS Outlook
• Willingness and ability to learn new applications