Manufacturing Process Lead

3 weeks ago


Ware, Hertfordshire, United Kingdom GlaxoSmithKline Full time

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:

  1. Develop and improve key quality processes, including change control, documentation management, deviation investigations, and CAPA creation and management.
  2. 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.
  3. Collect metrics, review data, and review in-use examples of resultant documentation and Gemba-related activities to understand performance of process and identify improvements.
  4. 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.
  5. Represent the site at central quality sessions to ensure key messages and expectations are taken and relayed across all site functions.
  6. 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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