Cache of job #13974048

Job Title

Incoming QA Specialist

Employer

Pe Global

Location

Dublin

Description

PE Global are currently recruiting for a QA Specialist for a client site in South Dublin - Job Description: The Sr. Associate in Quality Assurance (QA) will be an active member of the QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components. The Sr. Associate in Quality Assurance will report to a QA Senior Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components. The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, IQA Snr. Associates may be asked to carry out additional work functions to support site continuous improvement activities. Incoming Quality Assurance Sr. Associate Key Responsibilities. • Testing of primary and secondary components for use in the manufacture of aseptic products. • Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities. • Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable. • Participates in customer complaint investigations with suppliers of components. • Provide training and advice to staff in relation to testing of components and packaging. • Actively participate in audits and their preparation. • Review and approve cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation. • Write, review and approve Standard Operating Procedures in accordance with Policies. • Perform all activities in compliance with safety standards and SOPs. • Support continuous improvement and Operational Excellence initiatives. • Any other tasks/projects assigned as per manager’s request. Basic Qualifications & Experience: • University degree. Engineering or Science related discipline preferred. • Relevant experience (4 yrs. +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role. Preferred Qualifications & Experience: • Excellent written and verbal communication skills. • Experience working with dynamic cross-functional teams and proven abilities in decision making. • Strong organizational skills, including ability to follow assignments through to completion. • Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations. • Experience working in aseptic operations, protein formulation, vial and syringe filling. Interested candidates should send their CV to Audrey.mccarthy@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

1929 days ago

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