legal
Posted 4 days agoSenior Manager, Process Compliance Review and Analysis
at Fortrea
Pune, IndiaOn-site
Responsibilities
- Drive implementation of best practices and process improvement 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.
- 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 regulatory and client
- Ensure implementation of Quality Management Plan and/or the Quality Agreement for assigned projects.
- Support Computer System Validation related activities as required.
- Perform a critical role to ensure organization wide inspection readiness at all times.
- Develop general or client-specific PV SOPs and WIs.
- Identify process improvements and support delivery teams in the implementation.
- Support practice head in developing process framework, new offerings, and customized solutions for clients.
- Support business development at practice level by contributing to RFP responses, proposals, and client presentations.
Requirements
- Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area.
- Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements.
- experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with