Job Overview:
It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a protected and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health & Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health & Safety Manual.
Summary of Responsibilities:
• Responsible for instituting and implementing a Quality process across designated PV and safety writing engagements.
• Accountable for quality, CAPA and compliance related deliverables for the assigned PV and Safety writing engagements.
• Drive implementation of best practices and process improvement for the assigned projects.
• Responsible for driving quality culture for the assigned projects.
• Drive CAPA management and audit readiness across projects.
• Identify quality trends and suggest corrective actions.
• Implement a feedback process and track implementation of feedback.
• Function as a Point of Contact for the delivery team for regulatory updates, quality assurance concepts, applicable procedures, practices, and conventions on the assigned projects.
• Act as the process and quality expert for the Client.
• Initiate and support initiatives for standardization of quality processes and process excellence across projects within the practice.
• Perform Analysis of data and if required, suggest strategies for process
improvement/excellence.
• Perform and Review of analysis of data performed and drive strategies for process improvement/excellence
Responsible for Driving Proactive Quality processes across the project.
• Oversee all aspects of quality reviews, metrics, analysis, outcomes, actions across the projects.
• Support internal audits of PV/ Safety writing projects as per the audit calendar and support as required for general systems and process audits.
• Oversee and conduct process reviews to ensure regu
📌 Senior Manager, Process Compliance Review and Analysis (Pune)
🏢 Fortrea
📍 Pune
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