QA Specialist (Batch Release)

Careerwise Recruitment

Limerick

QA Specialist required by CareerWise Recruitment for our Limerick based client. CareerWise Recruitment has been retained by a top multinational in Limerick with a well-known brand name. We are partnering with them to recruit a QA Specialist (Batch Release) with 3 years' experience to join their team on a permanent basis. Attractive salary and excellent benefits package on offer. Excellent learning experience for a strong driven candidate. THE ROLE: * Performs activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. * Responsible for preparation & review of batch disposition documentation to support QP release of Formulated Drug Substance. Activities include but are not limited to; Review of QC related release data, Documentation review, Compilation of deviation, Change control & batch record reports to support disposition. * Perform status labelling of products as required. * Represent Quality Assurance in support of deviations, CAPAs, etc., as required. * Provides consultation or advice in alignment with QA policies. * Review, edit, or approve controlled documents. * Interacts with various departments to ensure batch release deliverables are met. REQUIREMENTS: * Requires BS/BA in scientific discipline or related field and minimum 3-year relevant experience (relevant experience may be substituted for education requirement. * Understanding of biologics manufacturing operations is preferred. * Excellent organizational skills and attention to detail essential. * Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally. * Ability to prioritize, manage multiple tasks, and meet deadlines. Please contact Michelle Galvin on (091 373 938) mgalvin@careerwise.ie for further information on this exciting opportunity. 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.

1800 days ago