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Reference Number:
5117MO_ValidationQA
Job Description:
Work location is Hannibal, MO
Minimal travel to other sites may be needed (Willow Island, WV, or Kalamazoo, MI or Chicago Heights, IL)
Summary:
? Evaluates and performs quality functions primarily related to manufacturing processes and leading to the accurate and reliable validation of equipment, facilities and systems.
? Assists/performs investigations related to deviations, failures and/or process interruptions.
? Helps troubleshoot product problems. Responsible for familiarity with equipment and must possess ability to comprehensively explain their function and design. Responsible for developing validation methodology/approach with supporting protocol rationale/justification. Must have knowledge of quality systems and GMP requirements.
Responsibilities:
? Designs, implements validation protocols and guidelines to meet regulatory & business requirements.
? Leads, coordinates and tracks validation activities.
? Monitors and summarizes studies to ensure consistency of data production and compliance with cGMP. Issues/reviews data, memos & reports concerning validations, investigations, CAPA and quality improvements.
? Evaluates equipment or process problems and designs testing to determine possible causes or solutions; determines process capability of new equipment and assures defined parameters are incorporated into SOPs and batch documentation.
? Interacts with Production, Planning, Regulatory, Quality and outside resources as necessary to communicate administrative and technical information.
? Utilizes statistical analysis and other quality tools to provide input into cost reduction, quality improvement and controls.
? Develops and maintains divisional validation strategies and validation document management systems.
? Assists in audits, development activities, defense of validation documents during inspections, and mentoring of associates in validation & quality principles.
? Stays abreast of current industry, scientific and regulatory developments & incorporates into quality strategies.
? Prepares clear, concise, technically competent, regulatory compliant protocols, reports, documents and presentations.
Skills: -
? Thorough knowledge of cGMPs. Good working knowledge of industry and regulatory guidance documents related to validation.
? Must understand protocol acceptance criteria and corrective action/preventative action concepts.
? Excellent attention to detail with strong time management & follow-up
Education and experience:
? BS in Science related field or Engineering with 3 ? 5 years validation experience in GMP environment.
? Animal Health Industry or pharmaceutical experience desired.
? Must understand statistical concepts, product dosing, cleaning calculations/justifications and scientific data presentation.
? Must possess basic understanding of operation principles of mechanical equipment and ability to read technical instructions and plans
Experience Level:
Unspecified
Requirements:
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