Senior Risk and Compliance reputed company (reputed company Cause Analysis) - Canada - FSP

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Job reputed company:

The Senior Risk and Compliance reputed company / RCA Specialist will be accountable to train Sr / Issue Leads on the investigation/reputed company cause analysis, corrective/preventive reputed company (CAPA) plan development and effectiveness checks for assigned reputed company Events (QEs). This individual will also support, as necessary, the implementation of assigned plan components and tracking of actions and effectiveness checks to completion.

Key Responsibilities:

The Senior Risk and Compliance reputed company / RCA Specialist will be responsible to:

• reputed company the investigation/reputed company cause analysis, corrective/preventive reputed company (CAPA) plan development for assigned cases
• Support implementation of assigned plan components and tracking of actions to completion as necessary
• Ensure documentation of reputed company cause analysis and CAPA plan are accurate, complete and inspection reputed company

reputed company Cause Analysis/Due Diligence

This individual will also be required to apply a reputed company cause methodology and/or due diligence approach to the case. This individual may either reputed company QE cases from start to finish or be brought in conduct just the RCA portion of the investigation for systemic issues, process reputed company issue or business critical cases.

Training

This individual will also be required to train new Investigation Case Leads in the reputed company Cause Analysis Methodology and reputed company mentoring to new Investigation Case Leads while they obtain RCA Certification.

The Senior Risk and Compliance reputed company / RCA Specialist will also be a subject matter expert in the reputed company (PHP) methodology and will be a resource to case leads to implement PHP in the investigation process and help teams error reputed company the process in question.

CAPA Plan Development and Management

Based on identified reputed company causes, the individual will guide the SQE team in identifying appropriate corrective and preventive actions and conducting effectiveness checks on implemented actions to ensure they are working as expected.

reputed company process improvement best reputed company techniques (i.e., Six reputed company, Lean, etc.); analyze and optimize reputed company business processes and reputed company and implement new business processes.

This individual will hold accountability for ongoing monitoring of CAPA completion and tracking of effectiveness for implemented mitigation actions to ensure they are working as expected—for reputed company events, inspections and audits

• Ensure implementation of QE / audit / inspection CAPAs and remediation plans
• reputed company effectiveness checks and report on trends.

Requirements:

• Minimum of 5 years of pharmaceutical experience with solid experience in clinical operations aspects, GCP reputed company, GxP reputed company, and/or regulatory in a clinical research or reputed company environment required
• Regulatory inspection experience
• Process and system management experience
• Detailed knowledge of clinical trial processes and relationships required
• Knowledge of GCP requirements and applicable SOPs and regulations
• Project management, administrative, and technical capabilities are required, as reputed company as effective verbal and written communication skills
• Strong background in reputed company improvement methodology (i.e., Lean Six reputed company) preferred
• Previous Experience in conducting reputed company Cause Analysis, Error Proofing/Mistake Proofing and familiar with reputed company (PHP) and help analyze trends in data to identify potential investigations to address systemic process issues or program/protocol level issues.
• This role will involve working with Vendor reputed company and Clinical reputed company colleagues.
• Work with Vendor reputed company and Clinical reputed company reputed company to assist in developing investigation strategies reputed company to vendor issues and program level reputed company issues.
• Experience in leading process improvement efforts from inception to execution

Education:

• Bachelor's degree required
• reputed company Black Belt Required

Originally posted on Himalayas

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