Quality Validation Specialist

2 weeks ago

Quebec Province, Canada McKesson Canada Full time

**Job Summary**

Reporting to the Senior Manager, the Quality Validation Specialist will be responsible for the coordination,

tracking and recommendation on the equipment and temperature validation process, as well as computerized

system validation process. The incumbent will support any Regulatory inspection.

The Validation Specialist will be responsible for ensuring cGMP compliance of operations and continuous

improvement activities are established, monitored and maintained to ensure compliance with all applicable

regulations related to validation for McKesson Canada.

**Section A - Specific Responsibilities**

Certain responsibilities that are typically associated with a job as a Quality Validation Specialist are included in Section B. Specific duties include the above and also generally include but are not limited to the following:

- Serve as a delegate and contributor by providing support, assistance, training and recommendations to the stakeholders and specialists working on computerized systems, equipment and temperature validation
- Contribute to the development and maintenance of training programs to promote validation best practices (requirements in validation, maintenance and use of computerized systems).
- Collaborate with and support the IT department to address Regulatory issues and support achievement of Regulatory Compliance.
- Responsible for the impact assessments regarding change controls (i.e., facilities, equipment and process) that may affect temperature mapping and qualification studies.
- Participate in the review of Health Canada inspection reports as appropriate in relation to validation and qualification questions/issues to ensure responses are submitted to regulatory bodies within their deadlines.
- Collaborate with the Corporate Quality and Compliance Team to monitor ongoing progress and ensure appropriate corrective actions are implemented and effective.
- Develop and maintain GMP related documentation, including but not limited to documentation and remediation of deviations resulting from validations / qualifications, change control process, and qualification protocols. Ensure that Distribution Centers have certified copies of documents from the Corporate Regulatory Team and appropriate signatures are obtained.
- Analyze and provide interpretation on McKesson's Temperature monitoring system and route temperature profile system to Quality Site Specialists and increase the knowledge base across the National Regulatory Team.
- Develop, write and review validation and qualification protocols, templates and tools on an ongoing basis to ensure regulatory compliance to established internal and external criteria for equipment, cold chain/ambient packaging, computerized systems and premises.
- Execute validation and qualification protocols if needed.
- Review processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
- Produce validation reports as required including preliminary analysis, final analysis and recommendations.
- Manage and maintain the equipment, premises and computerized systems in a qualified and calibrated state.
- Troubleshoot and provide recommendations and solutions for identified validation and qualification issues based upon sound, scientific analysis.
- Schedule the necessary qualifications/re-qualifications with mínimal impact on operational activities as required.
- Collaborate to innovatively address Regulatory issues and support achievement of Regulatory Compliance.
- Provide guidance and knowledge on validation and qualification practices and methods.
- Monitoring and communicating performance review, compliance and other metrics updates to key stakeholders.

**Section B - General Responsibilities**
- Promote understanding of quality standards and processes within the company.
- Identify training needs and organize training interventions to meet quality standards.
- Support DCs in the preparation, execution and follow-up of regulatory inspections by maintaining qualification documents and response CAPAs.
- Maintain Good Documentation Practices.
- Act as a key contributor in a more complex/critical environment.
- Develop resolutions to complex problems that require the frequent use of creativity.
- Use judgment within broadly defined policies and practices.
- Anticipate change and directs or redirects efforts.
- Accomplish work without considerable direction and exerts significant latitude in determining objectives of assignment.
- Anticipate change and communicates potential solutions with the management team.
- Responsible to exhibit professional behavior with internal and external associates that reflects positively on the company and is consistent with the company’s policies and practice.
- Develop KPIs and metrics & support data collection.
- Complete Change Control, CAPA and Deviation processing and investigations as needed.
- Support other validation activities

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