Validation Analyst
Philadelphia, United States
Job Description
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
Performs validation activities to assure compliance to government and customer requirements.
Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.
Effectively communicates project goals and progress to Validation Supervisor/Manager
Reviews and interprets standards, procedures and specifications for dissemination relative to validation protocols.
Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.
This position may require overtime and/or weekend work.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position.
May perform technical writing in developing protocols and writing reports.
Execution of validation protocols
Perform Environmental Monitoring in operational and sampling areas.
Performs other duties as assigned by Manager/Supervisor.
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Career Focus: Project Management, Quality, Validation
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