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Job Overview

The role involves providing commissioning, qualification, and validation services to pharmaceutical and biopharmaceutical clients in various areas such as process equipment, CIP/SIP, and process manufacturing. The consultant will develop risk assessments, system impact assessments, protocols, and reports that support the qualification and validation requirements in the industry.

Key responsibilities include developing validation protocols using a science and risk-based approach, reviewing and analyzing system and process performance data, investigating deviations, and creating summary reports. The consultant will also exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Responsibilities:
  • Perform risk-based commissioning, qualification, and validation service for pharmaceutical and biopharmaceutical clients on one or more of the following areas:
  • Process Equipment
  • CIP / SIP
  • Process Manufacturing and related business processes including Quality Operations and Supply Chain Operations
  • Develop risk assessment, system impact assessments, protocols, and reports that support the qualification and validation requirements in the industry
  • Develop validation protocols using a science and risk-based approach that meets regulatory requirements and industry best practices
  • Review, analyze, interpret, and summarize system and process performance data of executed activities for report and presentation to management
  • Investigate deviations, write investigation reports, and create summary reports
Requirements

The ideal candidate will have at least a Bachelor's degree in a technical discipline such as engineering or science, with 3 or more years of experience in several functions in the pharmaceutical industry. They should have a foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4, and other regulatory requirements.

Preferred skills include experience with investigations into manufacturing/laboratory deviations and determination of product impact potential, root cause, and corrective/preventive actions. The candidate should also have knowledge of validation lifecycle approaches, guidelines, international regulatory requirements, and industry best practices.