Manufacturing Process Lead
3 weeks ago
Job Purpose:
We are seeking a highly motivated and experienced Quality Process Development Manager to join our team at GlaxoSmithKline. As a key member of our quality team, you will be responsible for developing and improving key quality processes that form the foundations of our Quality Management System (QMS).
Key Responsibilities:
- Develop and improve key quality processes, including change control, documentation management, deviation investigations, and CAPA creation and management.
- Act as Subject Matter Expert (SME) for key quality processes and manage key quality processes for audits to ensure processes are robust and inspection ready.
- Collect metrics, review data, and review in-use examples of resultant documentation and Gemba-related activities to understand performance of process and identify improvements.
- Develop and implement digital solutions to manage process and track performance, as well as communicate improvements across site and work with key stakeholders to secure resources to support improvement deployment.
- Represent the site at central quality sessions to ensure key messages and expectations are taken and relayed across all site functions.
- Develop and deliver training in processes through training sessions and ongoing coaching.
About You:
We are looking for a self-motivated individual with strong experience of working in quality and/or manufacturing at a complex manufacturing site. You will be resilient and calm under pressure, with strong people and communication skills and a proven ability to influence people to achieve objectives and drive performance.
Requirements:
- Relevant experience ideally gained working in a highly regulated industry, such as pharmaceutical manufacturing.
- Knowledge of current Good Manufacturing Practice (cGMP) requirements within major pharmaceutical markets.
- Knowledge and application of Quality Management Systems (QMS).
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