QC Method Validation Engineer

Overview:

Key Responsibilities:

• Execute Validation Protocols: Implement validation protocols as developed by senior-level resources. Follow established procedures meticulously to ensure accuracy and consistency in testing.
• Documentation: Maintain comprehensive and accurate records of all validation activities, including raw data, observations, and results.
• Compliance: Ensure all executed protocols and activities comply with regulatory guidelines, industry standards, and company policies.
• Collaboration: Work closely with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to support and align with method validation activities.
• Troubleshooting: Identify and address any issues that arise during the execution of validation protocols. Report problems and deviations promptly.
• Method Optimization: Assist in optimizing analytical methods based on execution results and feedback from senior resources.
• Stay Informed: Keep abreast of advancements in analytical techniques, industry best practices, and regulatory changes.

Qualifications:

• Education: Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field. Advanced degree preferred.
• Experience: Minimum of 5 years of experience in analytical method validation within a QC or laboratory environment.
• Skills:
  • Proficiency in executing analytical validation protocols and using analytical instrumentation.
  • Strong understanding of regulatory requirements and industry standards related to method validation.
  • Excellent attention to detail and organizational skills.
  • Ability to work effectively in a team-oriented environment.
• Technical Competence: Familiarity with software and tools used for data analysis and reporting.

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