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Associate, Quality Services

Canada
Permanent
Reference: 018102
Description

Mapi is a leading global organization, offering evaluation and support of therapeutic strategies. With offices worldwide, Mapi provides high quality and efficient operations to help our clients secure product approvals and reimbursement, as well as addressing post-marketing requirements and late-phase needs, meeting the needs of patients, physicians, regulatory authorities and health care technology purchasers.
 
Mapi is adding a Quality Services Associate to our team in North America!  The preferred location will be our Dundas, Canada office, and we will consider qualified applicants throughout North America.  Relocation assistance is not available.  The Quality Services Associate will build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients for GMP/GCP activities.
 
Responsibilities/Accountabilities:
  1. Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients.
  2. Facilitation of regulatory inspections for pharmaceutical sites through effective negotiation with Agencies.
  3. Release of pre-market and post market drug product for Canada.
  4. Maintain and adhere to current GMP/GCP practices. 
  5. Effectively prioritize and complete multiple projects within established timeframes.
  6. Lead, participate in and support project teams and advise other departments on quality issues and strategies. Identify client issues and develop alternate strategies for review by team members, as required.
  7. Act as mentor for team members(s) in order to facilitate integration to the company and required quality procedures. 
  8. Presentations of client services and training seminars, or participation as a speaker at industry-related conferences, when required.
  9. Other duties as assigned.
 
Qualifications:
  • B.Sc. in Life Sciences and/or Chemistry, an advanced degree (e.g. M.Sc. or PhD) an asset
  • Minimum 5-6 years directly related quality assurance or compliance experience within the pharmaceutical industry
  • Demonstrated GMP/GCP knowledge
  • Possesses sound knowledge of CAN regulatory framework and requirements.
 
Knowledge/Skills/Abilities:
  • Excellent written and verbal communication skills
  • Excellent computer skills with training in current software applications (MS Office & Adobe Standard)
  • Ability to maintain a high level of accuracy and attention to detail
  • Time management and multi-tasking skills
  • Excellent problem solving ability and analytical skills
 
  


 

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