GMP QA Operations Specialist
Company: Katalyst HealthCares & Life Sciences
Location: New York
Posted on: May 28, 2023
- 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
- 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
- Support and /or lead the execution of line trials, Engineering
studies, process qualification and process performance
- 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
- 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
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