Validation Analyst 2

PCI Pharma Services•Rockford, IL

About The Position

The Validation Analyst II is responsible for overall validation project management of intermediate customer accounts under moderate 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.

Requirements

High School Diploma or GED and/or 3-5 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.
Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations.
Ability to read various types of standard items addressed to general readers.
Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form.
Ability to deal with problems that involve several concrete variables in standardized situations.

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.
Attendance to work is an essential function of this position
Performs other duties as assigned.