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QA Senior Validation Specialist in West Caldwell, NJ at Synerfac

Date Posted: 8/7/2018

Job Snapshot

Job Description

SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
•Demonstrates and maintains a continuous state of qualified equipment and validated processes by writing Cleaning Validation, Design of Experiment, Process Performance Qualifications, Continuous Process Verification Protocols and Reports Plans and coordinates cleaning, manufacturing processes, facilities and equipment validation activities including risk analyses and FMEAs.
•Develops validation plans and schedules including annual cleaning verification schedule.
•Interacts directly with customer on cleaning assessments, deviations, and validation strategy for assigned projects.
•Coordinates validation activities with Manufacturing, Converting/Packaging, Quality Control and Technology Transfer departments.
•Assesses and approves deviations, changes to equipment and batch records for validation impact.
•Analyze data and work with Project manager to solve technical problems during development and/or scale up efforts.
•Review/approve calibration reports and work orders for validation impact.
•Review/approve master batch records, equipment, facility, calibration and maintenance SOP’s.
•Understands implementation and maintenance of Serialization on packaged product.

Job Requirements

QUALIFICATIONS/REQUIREMENTS:
•BS in Scientific discipline or equivalent.
•5-8 years’ experience in the Pharmaceutical Industry with minimum 3 years’ experience in cleaning, manufacturing processes, equipment and facilities validations.
•Knowledge of validation concepts and current cGMP (21 CFR Parts 210/211, Part 820 & Part 11, ICH)
•Experience in data compilation and review for statistical evaluation.
•Demonstrated experience in writing and reviewing validation reports.
Strong computer and interpersonal skills.
Must have Process Validation experience, Facility and Utility validation, and mechanical equipment validation experience.