Employment Spot

Job Description

Validation Specialist
for the Dallas/Fort Worth Metroplex
1st Shift Available.

This position requires an individual with a thorough knowledge of all aspects of pharmaceutical validation, compliance regulations, and excellent problem solving skills. Responsibilities will include the following: coordinate validation project activities, write and review validation policies/SOPs, develop and execute qualification protocols. Must have the ability to integrate differing solutions into a cohesive and well-structured quality plan. Using effective project management skills, must deliver projects on time and within budget.

Job Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES
Support the overall Validation Program by executing protocols, submitting samples and analyzing results. Prioritize validation activities. Communicate and document status to management and appropriate departments. Proactively seek quality solutions and develop corrective action plans, as required. Implement a team approach for validation activities with internal departments i.e., facilities, manufacturing and quality control. Develop and/or review IQ/OQ/PQ protocols, SOPs, technical reports and final reports. Execute protocols for support equipment and utilities. Operate data acquisition systems and testing instruments. Order and maintain testing supplies and instruments. Evaluate and perform requalification activities. Perform and track periodic reviews in accordance with the revalidation program.

ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE

BS/BA in Science or Engineering; 2-3 plus years experience in validation; Thorough understanding of cGMPs and all compliance regulations; Effective project management and decision making skills; Proficient in MS Office (computer skills)