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Validation Specialist

Lannett Company Inc.


Location:
Seymour, Indiana 47274
Date:
11/07/2017
2017-11-072017-12-07
Job Type:
Employee
Job Status:
Full Time
Shift:
1st Shift
Lannett Company Inc.
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Job Details

Responsible for supporting equipment qualification and process validation programs including creation and execution of protocols (including sampling and process monitoring) as well as writing/routing/obtaining approval of final reports. The specialist is expected to work cooperatively with Regulatory Affairs, Operations, Quality Assurance, Research & Development and Product Compliance.

Responsibilities

 

    • Create and coordinate approval of equipment qualification protocols and reports in line with established validation policies and procedures.
    • Create and coordinate the approval of process validation protocols and summary reports in line with established validation policies and procedures.
    • Create and coordinate approval of cleaning validation protocols/reports and associated documentation in line with established validation policies and procedures
    • Create and coordinate the approval of continued process validation verification plans/reports in line with established validation policies and procedure
    • Assure validation documentation is available for operation activities.
    • Responsible for assisting in the validation impact assessment regarding changes to validated systems and processes.
    • Troubleshoot/investigate validation-related issues.
    • Maintain completed validation and qualification packages
    • Execute or assist execution of approved validation and qualification protocols, requiring product monitoring and sampling and also communicating activities
    • Attend meetings as required to ensure validation activities are tracking to project schedules.

Requirements

  • High School Diploma / GED - Required
  • Bachelor’s Degree - Required, Master’s Degree or Ph.D. - Preferred
  • 5+years'experienceperforming equipment/facilities qualificationand/or Process Validation within the Pharmaceutical industry.
  • Working knowledge of various manufacturing process including those used granulation, drying, sizing, blending, compression, encapsulation, coating, printing, and laser drilling.
  • Knowledge of current applicable regulatory standards(FDA,CFR, ICH etc.
  • Experience in data analysis, technical report writing, root cause analysis, and risk assess
  • Strong initiative and integrity as well as strong written and verbal communication skills
  • Proficiency with Microsoft Office suite preferred.
  • Proficiency with Minitab, SAS, or other statistical data processing software preferred.
  • Ability to prioritize, organize, give appropriate attention to detail, and work effectively with minimal supervision including strong follow-up skills, and the ability to provide timely closure of assigned tasks is required
  • Competent in English (both written and verbal). Strong technical writing skills with attention to detail and verbal/written communication skills preferred.
  • Traditional office environment,with frequent walking too the areas of the facility, including production areas, loading docks, mechanical spaces and warehouse.
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