17 days old

Validation Specialist

Company Confidential
West Caldwell, New Jersey 07006
  • Job Type
    Employee
  • Job Status
    Full Time
  • Shift
    1st Shift

1. Basic Office Setting - Exposure to Computer Monitor

2. Physical Requirements - Not Applicable

3. Business Travel Not Required

4. Business Dress

5. Supports/Drives Process Validation Program (Process and Equipment) including Continued Process Verification (Stages 2 and 3 of 2011 FDA Guidance on Process Validation).

6. Supports/Drives Cleaning Validation and Verification Program.

7. Interacts directly with customer on deviations and cleaning and process validation strategy for assigned projects.

8. Reviews and approves batch records.

9. Reviews and validates Electronic Spreadsheets.

10. Supports Equipment Installation and Operational Qualifications.

11. Assesses regulatory impact of deviations, changes to equipment and batch records, materials, and calibrations from validation perspective.

12. Analyzes data and works with Project manager to solve technical problems.

13. Assumes supervisory role in absence of supervisor (for Sr. Level)

14. Additional duties and tasks assigned at the discretion of Quality Management.

Requirements

• Bachelor’s degree in science
• Minimum of 3 years in a Pharmaceutical Field or 7 years for Sr. Level
• Excellent reading, writing, and verbal
• Above average mathematic skills
• Proficient in word, excel and power point
• Experience in cleaning, manufacturing processes, equipment, and facilities validations.
• Knowledge of pharmaceutical process and equipment
• Knowledge of validation concepts and current cGMP (21 CFR Parts 210 & 21, 820 & Part 11). Extensive experience with Data Integrity Assessments and Computerized System Validations (for Sr. Level)
• Batch records knowledge and data review experience
• Demonstrated experience in writing and reviewing validation reports.
• Familiarity with Change Control Processes.

Categories

Posted: 2021-08-31 Expires: 2021-09-30

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Validation Specialist

Company Confidential
West Caldwell, New Jersey 07006

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