Validations Manager

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We are looking for a Validations Engineer/Manager for direct hire position at a leading contract pharmaceutical manufacturer specializing in OTC packaging. 

 

ResponsibilitiesManage all aspects of the validation department in accordance with current guidelines on validation and in compliance with FDA regulations.Develop new product, process, utility, and facility validation strategies.Develop and manage execution of comprehensive validation master plan.Manage validation maintenance for existing products and processes.Lead project teams and contribute directly to completion of projects.Approve document and equipment change requests related to validated systems.Prepare/review/approve validation protocols, reports and SOPs as required.Manage budget and resources for the team.Work with customers and vendors as required to assure products and processes are properly validated.Prepare data required for regulatory submissions and present data to regulatory agencies.Manage all aspects of the calibration department and assure compliance with applicable regulatory requirements and industry standards.Assure equipment, instrumentation, including environmental monitoring equipment, are maintained in a calibrated state.Identify new equipment that requires external or in-house calibration, and ensure test methods and acceptance requirements meet contemporary regulatory standards.Maintain a tracking system that identifies when equipment must be calibrated/recalibrated.Ensure calibration standards and measuring devices are properly maintained.Manage quality systems associated with documentation, the change control process, complaints, annual product reviews, and product investigations.Manage implementation and maintenance of Documentum ®.Transition product investigation responsibility into quality and manage timely completion of reports.

Qualifications

Candidates will have a BA/BS in Engineering (preferred), Chemistry or Microbiology with 5 - 10 years experience in the pharmaceutical industry with sterile/aseptic experience.  Candidates must possess a thorough understanding of cGMPs and current guidelines on validation (cleaning, computer, process, etc.) and have a basic knowledge of Analytical and Microbiology as related to the pharmaceutical industry and quality systems.

 

 

If you would like to be considered for this opportunity, send a copy of your resume to recruit@astrixtechgroup.com with Validations Manager in the subject line.