Cache of job #13942188

Job Title

QA Specialist - East Cork

Employer

Pe Global

Location

Cork

Description

PE Global is currently recruiting for a QA Specialist for a client site in East Cork - Description: QA Specialist. This role is based within the QA Quality Systems and Monitoring team at client site in Cork where the successful candidate will be involved in product complaint investigations, collation of annual quality reviews, support of document updates by authoring changes or reviewing changes from other departments and support for site training initiatives related to quality processes. This is an advanced position requiring significant expertise and specialisation in area of work. The successful candidate will be required to exercise judgement within well-defined and established procedures and practices to determine appropriate action with minimal supervision. Job Responsibilities • Performs a wider variety of activities to ensure compliance with applicable regulatory requirements. • Participates in the coordination and completion of product complaint investigations. • Participates in writing of annual product reviews. • Participates in developing SOPs to ensure quality objectives are met. • May conduct or serve as lead of investigations and CAPA recommendations related to manufactured products. • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP. • Develops solutions to more complex problems and identifies deviations from accepted practices and evaluates impact assessment as required. • Normally receives no instruction on routine work and general instructions on new assignments. Knowledge and skills • Demonstrates proficiency in GMPs. • Demonstrates proficiency in the application of QA principles, concepts, industry practices and standards. • Demonstrates thorough knowledge of FDA and EMA standards and quality systems and interfaces with other site functions. • Demonstrates strong knowledge of six sigma and root cause analysis tools used for identifying and correcting deviations. • Demonstrates investigation skills, report writing skills, strong verbal, technical writing and interpersonal skills. Prior experiences in a pharmaceutical industry is preferred, guideline of 4+ years in relevant field with appropriate BS or BA qualification. Interested candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

Date Added

2015 days ago

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