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Manufacturing Validation Specialist

Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 20091-AB1
Compensation : 90000.00 - 95000.00 USD/YEAR
Start Date : 01/10/2020
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering or Science
Travel : No
Relocation : No
Job Industry : Pharmaceutical

Job Description :

  • Permanent position for a Manufacturing Validation Specialist to validate and qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, policies and procedures.

  • Resolve deviations observed during execution of qualification and validation activities.

  • Responsible for reviewing, revising and approving qualification/validation protocols and reports.

  • Review and approve executed qualification and validation documents (IQ, OQ, PQ), for facilities, processes, and equipment in a cGMP regulated manufacturing environment.

  • Validate and qualify LIMS and other software systems.

  • Troubleshoot process issues, process characterization and root cause investigations.

  • Approve final reports summarizing the results of executed Validation, Qualification studies.

  • Prepare and issue change controls, CAPAs, and investigation reports after validation activities.

  • Participate in planning committee meetings to plan qualification and validation activities ensuring quality requirements are enforced.

  • Support all internal and external (e.g. cGMP, client, regulatory agencies) audits.

Required Qualifications :

  • BS Engineering or Life Science required.

  • Minimum 5 years of experience in validation in pharmaceutical manufacturing or related industry.

  • Familiar with FDA, ISO, and other regulatory agency guidelines.

  • Understanding of GMP, GDP, and GLP.

  • Experience in authoring and approving CAPAs, SOPs, Deviation reports, Investigation reports, and other documentation in a cGMP/cGTP environment..

  • Knowledge of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.

  • Experience in clinical and commercial manufacturing preferred.

  • Experience supporting or participating in health authority inspections and/or client audits preferred.

Contact: Allan Berman

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Please send all inquiries to Allan.Berman@TerkoTech.com


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