GMP QA Operations Specialist

Company: Katalyst HealthCares & Life Sciences
Location: New York
Posted on: May 28, 2023

Job Description:

Job Description
Responsibilities:

• Plan and execute multiple and/or key packaging equipment and validation assignments including key initiatives concerned with life cycle management initiatives and develop & deploy risk mitigation strategies to deliver project commitments. Lead and improve multiple and/or large scope packaging processes and various equipment technologies across multiple locations simultaneously.
• Lead, develop and execute packaging equipment and validation strategies for the site. Responsibilities include understanding existing limitations and developing technical solutions to eliminate roadblocks. He or she drives value through identifying and executing site projects by improving compliance, quality, efficiency and cost.
• Support and/or lead the development and assessment of the following types of information to support package development and life cycle management initiatives, including but not limited to the following activities: design requirements, definition of the scope of change, packaging and equipment solution proposals, prior knowledge and knowledge gap assessments, risk assessments, test plans, and test results analysis and conclusions.
• Lead, develop, write, and gain cross-functional alignment of packaging validation documentation for packaging equipment systems and processes.
• Support and /or lead the execution of line trials, Engineering studies, process qualification and process performance qualification.
• Provides proper project execution documentation (IQ/OQ protocols/reports) to support equipment qualification.
• Supports Production and Maintenance to start up equipment and run performance validation, execute, if necessary, secondary development programs to minimize impacts in production and speed up learning curves.
• Innovates through identifying new or state of the art technologies and proposes new ideas for improvement. Identifies opportunities (Cost Improvement Projects, capacity, capability) and assesses capital investment and cost impacts. Contributes to the BP Capital projects definition phase.

Keywords: Katalyst HealthCares & Life Sciences, New York , GMP QA Operations Specialist, Other , New York, New York