Science & Pharmaceutical JobsValidation Manager

  • CJ50929
  • Permanent
  • Waterford

Collins McNicholas

Job Title: Validation Manager

Role Responsibilities:

–          Stay current with client, EU, FDA and GAMP validation expectations, regulations, and requirements; interpret regulations and coordinate implementation into internal practices

–         Subject Matter expert equipment validation life-cycle including computerised system

–         Determine approach to validate specific laboratory systems and laboratory instrumentation

–          Provide training, trouble-shooting, technical and/or regulatory support to laboratory personnel

–          Research instrumentation with information obtained from vendors, manuals, industry resources, and other staff performing similar functions

–          Write and/or assist technical groups in writing validation protocols, test scripts, and related documentation in accordance with established validation program; review and approve documents written by other validation personnel for approach, GMP compliance, completion, consistency, and compliance to internal validation procedures

–          Write and/or perform 21 CFR Part 11 and Annex 11 evaluations and testing for computerized laboratory systems

–          Provide guidance and assistance to technical groups in this subject when required

–          Coordinate installation and execute testing (as required), document results, review documentation generated by vendors or other validation personnel, and summarize results obtained identifying compliance with the test plan

–          Create and/or assist technical personnel in creating procedures for new instrumentation to outline operation, maintenance, and calibration/qualification and data integrity requirements

–          Develop and implement quality programs, systems, and procedures to direct the validation operation; maintain validation policies and operating procedures ensuring compliance and best practices

–          Compile and maintain documentation in an organized manner to demonstrate status and present to clients

–          Accurately maintain all administration aspects of instrument validation program including but not limited to inventory reports, change control program, scheduling, database updates, and follow-up reports

–          Complete instrument vendor evaluations to assess level of compliance; write reports to communicate vendor status to management

–          Participate in internal, client, and regulatory audits; develop audit responses and corrective actions as necessary

–          Performs other duties as assigned

Role Requirements:

  • Previous experience in a GMP environment
  • 4-6 years industry experience
  • Subject matter expert of pharmaceutical processes for equipment calibration and validation.
  • Quality-oriented with the ability to consistently work to industry and client standards.
  • Bachelor’s degree in computer science, chemistry, biochemistry, microbiology or engineering

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