Senior Computer Systems Validation Professional

3 weeks ago


Rockville, Maryland, United States Quality Agents Full time
About Us: Quality Agents is a leading provider of validation and quality expertise to the pharmaceutical and biotechnology industries. Our team offers a unique combination of technical expertise and industry knowledge to support our clients' computer systems validation needs.

Job Description: We are seeking a highly skilled Computer Systems Validation Lead to join our team. The successful candidate will be responsible for leading the validation efforts of our clients' computer systems, including the development and execution of validation protocols, data analysis, and reporting. Additionally, the candidate will contribute to the development of standards and KPI reports to optimize our CQV support process.

Responsibilities:
  • Optimize CQV support process by developing standards and KPI reports
  • Analyze validation data and make recommendations for changes and/or improvements
  • Maintain all documentation pertaining to computer systems validation
  • Data integrity qualification
  • Participate in cross-functional project teams

Requirements: To be successful in this role, you will need to have a strong background in computer systems validation, with experience in writing validation master plans, configuration and design of data matrices, and IQ/OQ/PQ final reports. You will also need to have excellent leadership skills, strong communication skills, and the ability to work independently and as part of a cross-functional team.

Estimated Salary: $95,000 - $120,000 per year, depending on your level of experience.

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