Validation Specialist

2 days ago


MagstattleBas, Grand Est, United States Diverse Lynx Full time
Job Description

We are seeking a highly skilled Validation Specialist to join our team at Diverse Lynx LLC.

About the Role:

  • Develop and implement validation plans and protocols to ensure compliance with regulatory requirements.
  • Conduct risk assessments and identify areas for improvement in our validation processes.
  • Collaborate with cross-functional teams to ensure seamless integration of validation activities.
  • Stay up-to-date with changing regulatory requirements and industry best practices.

Key Responsibilities:

  • Validate software and hardware systems to ensure they meet regulatory requirements.
  • Develop and maintain validation documentation, including protocols, reports, and records.
  • Conduct training and awareness programs for colleagues on validation procedures and regulatory requirements.
  • Identify and mitigate risks associated with validation activities.

Requirements:

  • Strong understanding of regulatory requirements, including 21 CFR part 11, ALCOA, and GxP.
  • Experience with validation tools and technologies, including FTPS, PMX, and ERES.
  • Knowledge of pharmaceutical concepts, including CSV end-to-end lifecycle and GAMP 5.
  • Excellent communication and interpersonal skills.

What We Offer:

  • A dynamic and inclusive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

About Us:

Diverse Lynx LLC is an Equal Employment Opportunity employer. We promote and support a diverse workforce across all levels in the company.



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