QA Specialist

Careerwise Recruitment

Munster, Cork

A QA Specialist (contract position) is required by CareerWise Recruitment for our Cork based multinational Pharmaceutical client. A leading multinational currently has an opportunity to join their expanding team. THE ROLE: This role is based within the QA Quality Systems and Monitoring team 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. * 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. REQUIREMENTS: * 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 6 years in relevant field with appropriate BS or BA qualification. Please call Michael Hanrahan today for further information on 021-2019817 or email: mhanrahan@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. This job originally appeared on RecruitIreland.com.

1977 days ago