Validation Specialist

3 days ago

Wilmington, North Carolina, United States Quality Chemical Laboratories Full time
Job Summary:
  Quality Chemical Laboratories, a leading pharmaceutical testing and manufacturing laboratory, is seeking an experienced Computer System Validation Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the validation of computer systems meets the highest standards of quality and regulatory compliance.

About Us:
  Quality Chemical Laboratories is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are committed to delivering high-quality products and services that meet the evolving needs of our customers.

Responsibilities:
  
  • Perform and lead computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle.
  • Track and resolve deviations/exceptions during qualification activities.
  • Work with company management to implement changes and upgrades to computer systems.
  • Work with vendors on purchasing and planning for new lab equipment/software upgrades, review vendor protocols/design specifications.
  • Communicate Computer System Validation approaches and requirements during audits.
  • Review validated systems to assess need for further enhancements, validation, or system upgrades/fixes.

Requirements:
  
  • Two (2) years of experience with Computer System Validation in GxP environment (preferably pharmaceutical industry).
  • Experience in writing computer system test scripts, validation protocols and summary reports.
  • Knowledge of Regulatory Requirements, 21CFR11, Data Integrity Guidance, GAMP and industry best practices for validation.
  • Proficient in analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution.
  • Capable of managing multiple sub-projects, duties and tasks.
  • Effective at communicating clearly and concisely, both orally and in writing.
  • Able to work both independently and as a member of a cross-functional project team.

Benefits:
  Quality Chemical Laboratories offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company.

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