Quality validation Specialist @ McKesson

Job Information

Job Description:

  • 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 minimal 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.

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 as required.

Key Requirements

Education and Experience:

  • Bachelor of Sciences in Chemistry, Biology or in a related field, preferably with IT knowledge.
  • 3-5 years of work experience in a pharmaceutical/life sciences industry in Validation or Quality.
  • Preferably 1-3 years experience with computer system validation (CSV) across GxP landscape
  • Demonstrated experience with Canadian GMP requirements and other applicable regulations/guidelines pertaining to validation of computerized systems and controlled temperature environments.
  • Strong computer skills including Microsoft Office and databases.
  • Experience with development and implementation of qualification and validation programs.
  • Experience with quality risk management programs.
  • Experience conducting Quality investigations.
  • Experience with controlled environment monitoring programs/systems, considered an asset.

Knowledge and Skills:

  • Knowledge of current regulations and best practices, including, but not limited to, GMP, PICs, Annex 11, GAMP 5.
  • Strong knowledge of Health Canada’s GMP Regulations including those applied to wholesalers and distributors/importers.
  • Knowledge of regulations and guidelines for temperature control of drug products during storage and transportation.
  • Knowledge of validation tools, concepts and methodologies.
  • Strong analytical skills, excellent interpersonal, written & oral communication skills.
  • Good judgment and decision-making.
  • Ability to work independently with minimal direction
  • Ability to act as a SME during internal and external audits.
  • Strong time management and prioritization skills, with ability to manage multiple projects simultaneously.

Experience Level: Mid-Senior
Work From: Onsite

Company Information

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