Operational Quality Specialist

CPL

Sligo

Operational Quality Specialist My client, an international pharmaceutical company, are currently seeking an Operational Quality Specialist to drive continuous improvement within the company. Responsibilities : • Receive and investigate customer complaints/supplier complaints. • Issue, support, monitor and track to completion all deviations and CAPAs. • Issue, support, monitor and track technical change requests for the Value Stream. • Support the PIRC/LIRC process. • Approve changes to quality documentation within the Value Stream. • Generate Product Quality Reviews. • Review and approval of quarantines raised within the Value Stream. • Perform L1/L2 audits within the Value Stream. • Generation and reporting of quality KPI to quality council. • Review and approve RCA’s. • Supporting L3 and L4 Audits. • Conduct GMP Gemba’s. • Engagement with senior leaders within the site on all quality issues impacting their area. • Play a key role during investigations into significant incidents that have resulted in non-conforming products or compliance failures. Qualifications and Experience: • Minimum of 2 years’ experience in a quality role within a Pharmaceutical / Medical Devices / GMP environment. • High level of accuracy and attention to detail. • Ability to convey information clearly and accurately to groups/individuals verbally and in writing. • Ability to prioritise and manage multiple tasks effectively. • Ability to make decisions and take necessary actions. • Good analytical skills. • Thorough knowledge and understanding of regulatory requirements and application in a manufacturing environment. • Engage in / lead design of solutions and improvements. • Experience in auditing. • Identification and implementation of process efficiencies. Education Level 8 in a Science or Quality discipline. MSc or Post Grad in a Science or Quality discipline. Suitable applicants should email [email protected] /* */ or call me on 01-6146007 for a confidential conversation.

3474 days ago