Cache of job #14158877

Job Title

QA Specialist, Micro Support (12m, Cork)


CareerWise Recruitment




QA SPECIALIST, MICRO SUPPORT required by CareerWise Recruitment for our BioTech client in Cork, initial 12 month contract on offer. The QA SPECIALIST, MICRO SUPPORT provides support and direction to the QC department in respect of specific quality system elements to ensure business, quality and compliance goals are met. THE ROLE: * Supports the QC Laboratory in root cause problem solving for non-conformances and coaches QC personnel in the documentation of non-conformance reports ensuring that investigation review timelines are met. * Review & Approval of non-conformance and invalid assays in the quality event management system. * Assessment, review and approval of QC changes in the site change control systems. * Supports all QC validation activities as described in the Site Validation Master Plan, including the review and approval of validation protocols, exceptions and reports. * Reviews and approves SOPs/work instructions/forms on behalf of Quality Assurance. * Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site and supports the QC Laboratory audit readiness program. * Perform GMP audits on-site and in the QC Laboratory as required. REQUIREMENTS: * Honours Degree in a scientific/technical field required. * Knowledgeable of QC microbiological techniques used in the pharma/biopharma industry. * Excellent knowledge of root cause problem solving techniques and CAPA generation. * A minimum of 3-5 years' experience in a quality role within the biological and/or pharmaceutical industry. * Proven knowledge and application of industry regulations as they apply to quality, including those of FDA, HPRA, EMA and other authorities. Please call Conor Twomey today for further information on 087-0907204 or email: 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.

Date Added

57 days ago