Senior Specialist, Quality Assurance

Shoppers Drug Mart - Mississauga, ON (il y a 30+ jours)

Postuler dès maintenant

1685 Tech Ave, Mississauga, Ontario, L4W 0A7

Take ownership and find more ways to care about our local store owners in a career at Shoppers Drug Mart Central Office / Store Support. Provide great service, specific expertise and actionable advice to support Associate-Owners and their staff in delivering the best health, beauty and convenience services to Canadians.

Why this role is important?

The Senior Specialist, Quality Assurance is responsible for ensuring quality systems work properly and in compliance with Good Manufacturing Practices (GMP) and Canadian Medical Device Regulations. Lead internal investigations, liaise with customers concerning quality decisions when required, make product release decisions, and develop and maintain tracking and trending reports for Quality Systems.

What You'll Do:
Managing Complaints, Incidents, and 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.

Investigations, Change Control, and CAPA

Track investigation status and corrective actions and update spreadsheets.

Support the execution of trending reports and distribution to department managers as applicable.

Facilitate timely approval and closure of investigation records by performing follow-up activities and correspondence with required personnel.

Coordination and facilitation of activities as required to support product quality and control.

Ensure accurate tracking and control of change control documents and CAPA requirements.

Wholesale Product Release

Assess all drugs and medical devices as per current procedures for release purposes.

Facilitate timely resolution during the release process.

Assessment of Drug Product against Health Canada regulations (i.e. Active License, Labelled correctly,

no temperature excursion etc.).

Participate in warehouse inventory reconciliation activities as required.

Continuous Improvement and Metric Reporting

Liaise with co-workers to identify and implement Quality Improvement initiative.

Provide period or monthly reporting as required on select KPIs.

Co m plia n ce p roj e cts a s as s ig n e d

Review regulatory updates / changes and implement if applicable.

Review and/or approve procedures and/or other pertinent GMP documentation

Manage the ex e cution of crit i cal proc e s s Validatio n , equip me nt / faci l iti e s / s o f tware q u ali f ication

Managing Returns, Preventative Maintenance, and Facility Temperature Monitoring

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.

Work with Operations/Finance teams to ensure that refunds are reclaimed.

Managing the preventative maintenance program (HVAC, Calibration of Temperature Sensors).

Oversight over the temperature monitoring of all drug GMP facilities.

Prepare semi annual temperature monitoring reports, evaluate and assess any trends.

Conduct GMP related employee/contractor training sessions

Audits , Recalls and Validation

Support Customer audits, perform supplier and internal audits

Manage recalls

Validation (which includes writing of protocols & reports), calibration and GMP sanitation activities

What You'll Need:
Bachelor’s degree (B.Sc.) in science (microbiology, biochemistry, chemistry) or equivalent

Three (3) to five (5) years’ experience in quality assurance in the pharmaceutical industry.

Experience with validation (warehouse mapping and temperature controlled shipping) preferred.

Proficient knowledge of Canadian GMPs and Medical Device Regulations.

Proficient knowledge of Microsoft Word, Excel, and PowerPoint in a Windows environment.

Organizational skills and ability to manage several projects or tasks at once; results oriented

Thoroughness and concern for a job well done.

Excellent analytical skills and ability to focus.

Excellent oral and written communication skills in English.

Team spirit, open-mindedness and ability to communicate effectively with tact and diplomacy.

Why work at Shoppers Drug Mart?

Acting as consultants, supporting internal customers and the Associate-Owners, you will get experience unique to the retail industry while working for an award-winning national brand. Benefit from a purchase discount program, competitive pay and online learning through SDMU.

Take ownership of your work and find more ways to care about your work, co-workers, customers and community.

How You’ll Succeed:
At Shoppers Drug Mart Inc. , we seek great people to continually strengthen our culture. We believe great people model our values, are authentic, build trust and make connections.

If that sounds like you, and you are open-minded, responsive to change and up to the challenges provided in a fast-paced retail environment, apply today.

Employment Type:
Full time

Type of Role:

Shoppers Drug Mart Inc. recognizes Canada's diversity as a source of national pride and strength. We have made it a priority to reflect our nation’s evolving diversity in the products we sell, the people we hire, and the culture we create in our organization. Accommodation is available upon request for applicants with disabilities in the recruitment and assessment process and when hired.

In addition, we believe that compliance with laws is about doing the right thing. Upholding the law is part of our Code of Conduct – it reinforces what our customers and stakeholders expect of us.

Please Note: If you have Employee Self Service (ESS) on Workday, apply to this job via the Workday application.