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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