QA Validation- Steam SterilISAtion

Harmonics Recruitment

Clare, Limerick

Job Summary and Essential Functions: QA-Validation Specialist responsible for the development and execution of steam in place sterilization and sanitization of process equipment. Implementation of company policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards. Essential Duties and Responsibilities: Generates, executes, reviews, approves, master and completed qualification/validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Prepares equipment for qualification studies, executes qualification and validation studies according to approved protocols and SOPs. Analyzes the results of testing and determines the acceptability of results against pre-determined criteria. Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements. Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions. Initiates, reviews, edits and approves change control and SOPs. Coordinates with other departments or outside contractors/vendors to complete validation tasks. Trains/advises less experienced Specialists and Technicians. Day to day management and oversight of sterilization contract specialists.Assesses quality system documentation for completeness and accuracy, and dispositions documentation per company’s SOPs. Manages projects and prepares status reports. Knowledge and Skills: Ability to comprehend regulatory requirements and technical documentation. High level of emotional maturity and self-confidence. Extensive experience in Steam Sterilization of biopharmaceutical process equipment. Strong knowledge of cGMPs for biotechnology. Excellent written and oral communication skills. Education and Experience: Requires a BEng/BSc in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field; will substitute relevant experience for education. Qualification/validation experience required. This job originally appeared on RecruitIreland.com.

2743 days ago