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.
Benefits:
Experience Level: Mid-Senior
Work From: Onsite
Company Information
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