Job Description

POSITION:

Quality Specialist (16 month Contract)

LOCATION:

Canada

DEPARTMENT:

Regulatory Affairs and Quality Assurance

RESPONSIBLE TO:
Director, Regulatory Affairs and Quality Assurance
POSITION SUMMARY:
The Quality Specialists key role is to ensure LEO products are manufactured and distributed
according to Canadian Food and Drugs regulations. This function maintains quality compliance
with Good Manufacturing Practices (GMP) and LEO Standard Operating Procedures (SOPs). The
quality function also ensures the timely release of incoming product batches into the
marketplace for sale, assisting LEO Pharma Inc. in meeting financial sales targets and ensuring
that quality product is available to patients.
JOB INTERACTIONS AND INTERFACE:
Internally this position interacts with all departments at LEO Pharma, in particular Logistics and
Medical Information, and LEO Corporate Quality Assurance. Externally this position interacts
with Health Canada (Inspectorate), third-party logistics, wholesalers and distributors, industry
organizations, consultants, vendors, and health care professionals.
GENERAL RESPONSIBILITIES:
Quality Assurance - Responsible for the following:
coordinating new launch shipments
handling of product complaints
development, periodic review, revision and implementation of SOPs as required
annual product reviews and review of stability reports for compliance with Canadian
registration
QA annual self-inspection and quality agreements with manufacturers, wholesalers and
distributors
conducting inspections of distributors and wholesalers as necessary per GMP requirements
acting as primary quality contact person with Third Party Logistics (3PL) and as qualified
person for internal quality compliance matters
implementing recall procedures if necessary
monitoring QA aspects of warehousing practices for compliance with warehouse procedure
manuals (Third Party Logistics-3PL).

liaising with customers and regulatory authorities regarding quality matters, including
hosting inspections and responding to observations.
training of sales representatives on physician sampling handling and distribution
overseeing the maintenance and renewals of Drug Establishment Licence(s)
periodic GMP training for relevant staff

Quality Control -Responsibilities include:

Timely approval of incoming batches, batch inspection and release according to LEO SOPs
Handling deviations
Monitoring stock transfers and physician sample lockers for compliance with labeled
storage conditions
Maintaining retained samples according to GMP
Maintain QC master files for all registered products

Miscellaneous:
Manage outsourced activities and consultants as needed
Responding to Canadian Environmental Protection Act (CEPA) registry notices
Act as back up to CMC regulatory specialist as needed.
Participate in personal development and training sessions.
Work in a safe manner that does not endanger yourself or co-workers.
Strive to consistently uphold LEO Pharmas core values.
Execute other duties as may be required by the Director RAQA

SUPERVISORY RESPONSIBILITIES (CHECK AS APPLICABLE):

This position has no supervisory responsibilities
Provides work direction only
Provides work direction and gives input on hiring, promotions, transfers,
performance management, discipline and termination
Provides work direction plus has responsibility for hiring, promotions, transfers,
performance management, discipline and termination

WORKING CONDITIONS AND ENVIRONMENT:

Normal business environment.

Occasional travel for training and third party inspections

SKILLS AND QUALIFICATIONS:

B.Sc. in Science, with analytical chemistry/manufacturing background

5 plus years relevant experience in the regulated pharmaceutical industry, specifically

including Quality Assurance, Quality Control, and/or Drug Regulatory Affairs
Experience with Health Canada GMP inspections and third party audits
Understanding of pharmaceutical manufacturing and laboratory work (including
familiarity with various analytical techniques) a strong asset
Detail oriented person
Solid decision making skills.
Excellent communications skills (verbal, written, listening, conveying messages)
Solid computer skills, using MS Office, MS-WORD and Lotus Notes