Responsibilities and Requirements :
- Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and client's corporate principles, quality policies, standards, and core values.
- You will work closely with instrument vendors, facilities, IT, and lab personnel to coordinate the installation and the qualification including computer system validation, of QC Equipment.
- Perform qualification of laboratory equipment following EQ policies, plans, and procedures.
- Coordinate with laboratory personnel to define qualification requirements.
- Author, review, and execute equipment qualification protocols.
- Coordinate equipment qualification activities with vendors and other support groups.
- Coordinate equipment maintenance activities with vendors and other support groups, as required.
- Identify business, quality, and compliance gaps and propose and implement potential improvements to systems and procedures.
- Sign documents for activities as authorized and described by the client's policies, procedures, and job descriptions.
- Provide input to technical / investigation reports.
- Identify, troubleshoot, and propose a resolution to technical problems.
- Receive and provide training.
- Provide input to and participate in assay transfer / validation associated with equipment qualification / lifecycle.
- Coordinate with customers to support multi-site operational activities.
- Present equipment lifecycle and associated procedures / material during internal and external audits and regulatory inspections.
- Works to meet schedules and set timelines.
- Perform other duties as requested by managers to support Quality activities.
- Bachelor's degree (Life Science, Engineering).
- Three to six years of validation experience (or equivalent experience) in a cGMP environment with increasing levels of responsibility for a wide range of validation projects including validation of large-scale biochemical manufacturing, utility, and automation system.
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