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

	cGMP Auditing Associate:

As a Q&C® cGMP Auditing Associate, you will evaluate conformance to regulatory standards (e.g., FDA, Health Canada, etc.). Activities include: coordinating audit arrangements, organizing and reviewing background documentation, preparing audit plans, performing audits at various locations, preparing audit reports, and providing advice related to the steps needed in order to be compliant with all components of the regulatory standards.

Required Qualifications:

• Minimum University degree, B. Sc. in a scientific field
• Minimum five (5) years previous experience with US and Canadian regulatory standards for drug products, natural health products, narcotic and controlled substances, and cosmetics
• In-depth knowledge of North American and International regulations and guidelines including cGMP/GLP
• Ability to negotiate priorities and audit findings, and the implementation of corrective actions
• Excellent project management and computer skills
• Some travel required

	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

	Sales & Marketing Associate:

Responsibilities

As a Sales & Marketing Associate for Q&C®, you will respond to Requests for Proposals by managing the price list, writing proposal content and legal agreements and coordinating review and approval. Once signed, the Sales & Marketing Associate initiates projects. The incumbent will respond to general and sales enquiries, as directed.

The Sales & Marketing Associate is responsible for implementing the annual marketing program and ongoing activities, including:

• Creating and distributing monthly e-newsletters, quarterly mailers and e-mailers
• Writing and editing white papers and website advertisements
• Preparing and organizing tradeshow collateral, white papers
• Implementing search engine optimization techniques

Activities also include maintaining the corporate websites and managing regular updates to pharmaceutical industry booklets, including content revision and coordination of desktop publishing, cover and ad design, printing and translation.

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
• Superior communication skills
• A flexible personality style

Minimum Qualifications

Education:

• Post-secondary degree or diploma in Communications, Marketing or Business
• Minimum three (3) years previous experience in a technical field

Computer skills:

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