Quality Systems Specialist- Contract

McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Canada, we touch the lives of 12 million Canadians every day. We carry more than 35,000 products in 12 distribution centers and ultimately provide distribution to 6,300 retail pharmacies, 1,350 hospitals, long-term care centers, clinics and institutions all over Canada. But we're so much more than a distribution company. We've automated 2,500 retail pharmacies and dispense over 100 million doses a year through our automation solutions. Manufacturers, healthcare providers and patients count on us for a full range of services that contribute to the quality and safety of care for us all.

At McKesson Canada, you’ll help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.

Reporting to the Quality System Manager, the Quality Systems Specialist, will be responsible for the creation and tracking of Complaints. The incumbent will be responsible for supporting the creation of change control, deviations, CAPA, Annual product review, Stability, etc.

The Quality Systems Specialist will be responsible for ensuring cGMP appropriateness of operations and continuous improvement activities are established, monitored and maintained to ensure compliance with all applicable regulations, SOPs and company for the private label and McKesson wholesale business units.

**Specific Responsibilities**
- Process owner of the Complaints process.
- Write quarterly complaint trend report reports and communicates in a timely manner finding related to documentation issues including but not limited to delays in receiving documentation from suppliers, investigations etc.
- Initiate and complete Change Control, Deviation, and Corrective Action and Preventive Action (CAPA) in collaboration with the fabricators.
- Act as a back up for Annual Product and the Stability Program.
- Compile KPI data to perform trends analysis and create applicable reports.
- Provide data for preparation of monthly/quarterly Quality Systems reports including quality issues, metrics and summary of any quality problems.
- Communicate with internal /external stakeholders to resolve quality issues.
- Participate in product recall process.
- Assists risk assessment process.
- Conducts troubleshooting for the Quality management system and audit trails review.
- Participates in the GMP annual training.

General Responsibilities
- Participate in the creation and revision of Standard Operating Procedures (SOPs) and Working Instructions (WIs).
- Participate on preparation of Health Canada/Corporate inspections, creation of corrective actions and action plan.
- Ensure GMP training compliance.
- Support or lead special projects and assignments as needed.
- Remain current on legislative, regulatory and technical changes

**Position Key Requirements**

**Education**:

- Bachelor of Sciences in Chemistry, Biology or in a related field.

Technical and Soft Skills:

- More than 5 years of work experience in pharmaceutical industry in Quality Assurance.
- Strong knowledge of Health Canada's GMP Regulations including those applied to wholesalers and distributors/importers.
- Documentation management, quality systems, and finished product release expertise.
- Experience of electronic Quality Management System in an established QA function within pharmaceutical/healthcare industries.
- Knowledge of Microsoft Suite: Outlook, Word, Excel and Power Point
- Bilingual (spoken/written English and French).

Management skills:

- Excellent organizational and time management skills with ability to manage several projects at once.
- Meticulous and detail oriented.
- Strong analytical skills, excellent interpersonal and written & oral communication skills.
- Proactive and strong team player.
- Ability to work independently and make decisions based on judgment and integrity.
- Works well under pressure.

Career Level - IC - Professional - P3

**Worker Type**
Fixed Term (Fixed Term)

**McKesson is an Equal Opportunity employer.**

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The information on this site is for information purpose only and is not intended to be relied upon with legal consequence.

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