Quality Assurance Associate Job at Shoppers Drug Mart Specialty Health Network Inc

Job Title:    Quality Assurance Associate - Specialty Health Network (Dartmouth, NS)
Job Ref:    8563
Job Location:    Dartmouth, Nova Scotia
Employer:    Shoppers Drug Mart Specialty Health Network Inc
Job Type:    Regular (37.5 hours per week)
Requisition No: 1036994
Store Number:   6003-SHN
About Us
Shoppers Drug Mart Specialty Health Network Inc. ("SDM Specialty Health") is a wholly owned subsidiary of Shoppers Drug Mart Inc. SDM Specialty Health is Canada's unique provider of client-focused healthcare products, services, and patient support programs. Being successful at SDM Specialty Health means you've enhanced a patient's life, and we do that every day! All across Canada, our team provides a number of services directly to patients; these brand-focused programs, sponsored by pharmaceutical companies, help patients manage and optimize their drug and medical therapies in the community.
We employ various healthcare professionals, and dedicated support staff to ensure the success of the team. With hundreds of employees across Canada, were proud to be able to offer a family-oriented environment that gives staff greater control over their own life choices.

Job Description
Reporting to the Director, Regulatory and Quality Assurance, the Quality Assurance Associate is responsible for ensuring and supporting Quality Initiatives and Good Manufacturing Practices (GMP) regulatory compliance. The QA Associate must have a solid understanding of GMP compliance requirements in relation to importing, distributing and wholesaling of pharmaceutical drug products and medical devices.

Job Requirements:
* Two (2) to Three (3) years of previous experience in regulatory/compliance in the pharmaceutical industry
* Strong knowledge of current Canadian, US and EU GMP regulations and guidelines
* Previous experience writing SOPs and technical writing and document management
* Proficient in the use of Microsoft Office; Excel, Word, PowerPoint.
* Ability to work independently, and as part of a team and collaboratively across the organization
* Ability to prioritize and schedule daily activities, manage multiple priorities, and requests under tight time constraints
* Excellent analytical and problem solving skills
* Outstanding communication skills, written and verbal
* Customer focus, results oriented with excellent organizational skills

Job Duties:
* Incidents/Complaints/Deviations
* Track corrective actions and update spreadsheets
* Prepare weekly incidents and monthly trend reports and distribute to department managers
* Retrieve defective drugs & devices from the field and assist in sending back to manufacturers for investigation, credit and or replacement
* Facilitate timely approval and closure of complaints
* Perform and document investigations as they relate to activities performed by QA on site.
* Support investigation of deviations and participate in decision making for quality issues

SOP management;
* Review and redevelop SOPs, edit, re-write and print new SOPs, retire old SOPs, update master and obsolete hard copy manuals. Review and update the internal SOP library to ensure accuracy of information.

Manage returns;
* Receive expired and or rejected drugs and devices
* Review, and facilitate investigation of returned drugs
* Track expired products
* Coordinate disposal with Contractor to ensure that rejected and expired drugs are disposed appropriately
* Work with Operations/Finance teams to ensure that refunds are reclaimed

 Quality Improvement Initiatives
* Liaise with co-workers to identify and implement Quality Improvement initiatives

Change Control
* Manage the CCF process and ensure accurate tracking, approval and control of the CCFs.

 Product Release
* Assess all drugs and medical devices as per current procedures for release purposes
* Facilitate timely resolution during the release process

General
* Liaise with Tech Avenue location to offer timely approvals required for site-related Quality/GMP issues
* Provide period or monthly reporting as required on select KPIs to the Director, Regulatory & Quality Assurance
* Update Training Matrix for SOPs for the worksite
* Minimal travel (<10%) as required

Deadline Date: 27-02-2014

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