Validation Analyst 3-1

PCI Pharma Services•Rockford, IL

1d•$27 - $31•Onsite

About The Position

The Validation Analyst III is responsible for overall validation project management of large customer accounts under minimal supervision. Responsible for generation and execution of validation protocols, assistance in customer audits, and determination of customer validation needs. This job has no supervisory responsibilities. Performs validation activities to assure compliance to government and customer requirements. Prepares validation protocols, validation statements, and master validation plans for new customer / product / system project launch and maintaining existing validated processes / programs at multiple sites as well as organizing and coordinating internal and customer approvals as needed. Ensures validation package documentation completion, accuracy, and closure including organizing and coordinating internal and customer approvals. Prepares change control and validation history report for customer audits. Attends conference calls and customer meetings and effectively communicates project goals and progress to Validation Supervisor / Manager. Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete project. Customer contact for quality validations activities and manage customer expectations. Reviews and interprets customer standards, procedures and specifications for dissemination relative to process and cleaning validation protocols. Reviews production jacket and issuance to ensure that documents meet internal requirements for standards and procedures. Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements. Required to pass and complete a “Documentation Boot Camp” course. This position may require overtime and/or weekend work. Attendance to work is an essential function of this position Performs other duties as assigned.

Requirements

Associate's Degree in a related field and/or 1-3 years related experience and/or training.
College Level Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Nice To Haves

Ability to effectively present information to various people as the job requires.
Ability to follow instructions and respond to management direction.
Ability to identify and resolve problems in a timely manner.
Ability to display a willingness to make decisions.
Ability to display excellent time management skills.
Ability to set and achieve challenging goals.

Responsibilities

Performs validation activities to assure compliance to government and customer requirements.
Prepares validation protocols, validation statements, and master validation plans for new customer / product / system project launch and maintaining existing validated processes / programs at multiple sites as well as organizing and coordinating internal and customer approvals as needed.
Ensures validation package documentation completion, accuracy, and closure including organizing and coordinating internal and customer approvals.
Prepares change control and validation history report for customer audits.
Attends conference calls and customer meetings and effectively communicates project goals and progress to Validation Supervisor / Manager.
Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete project.
Customer contact for quality validations activities and manage customer expectations.
Reviews and interprets customer standards, procedures and specifications for dissemination relative to process and cleaning validation protocols.
Reviews production jacket and issuance to ensure that documents meet internal requirements for standards and procedures.
Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.
Required to pass and complete a “Documentation Boot Camp” course.