Cache of job #13939793

Job Title

QA Specialist - South Dublin

Employer

Pe Global

Location

Dublin

Description

PE Global are currently recruiting for a Quality Assurance Specialist for a client site in South Dublin - QA Specialists may be assigned specific oversight & responsibilities for key QA Specialist Quality Systems & Compliance. The QA Specialist is a senior & active role within the broader QA function. The QA Specialist will typically report to a QA Senior Manager & will be required to be a Subject Matter Expert in their assigned area of responsibility. QA specialists will be required to understand & grasp a broad range of quality related competencies. In addition to routine QA duties quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within site, including Supply Chain, IS, Manufacturing, Process Development, Validation, Engineering and QC. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives. General QA Specialist Responsibilities: Perform all activities in compliance with safety standards and SOPs. Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely. Write, review and approve SOPs in accordance with Policies. Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems. Review and approval of NCs and associated 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. Provides training and advice to staff in order for them to perform their desired functions. QA Specialist Quality Systems and Compliance (may perform some of all of these duties. Responsibility and oversight for the development and maintenance of site quality systems, quality compliance and auditing related procedures and processes, including but not limited to, Documentation Mgmt , Change Control, NC/CAPA processes, Internal auditing/self-inspection program, Complaints , Quality Mgmt Systems and the overall Quality Mgmt review process. Ensures that the self-inspection, audit and key compliance systems are effectively implemented, revised and optimised to ensure a continuous drive to improve product and process quality at the site. Oversee and maintain site inspection readiness program and for Hosting of inspections (self-inspection and regulatory/corporate inspections. Manage inspection outcomes, including inspection response compilation and tracking. Oversee and implement Quality Agreements relating to area of responsibility. Keep abreast of regulatory initiatives and new guidance/requirements and for the communication of revised guidelines. Responsible for sustained compliance initiatives, including execution of gap assessments in support of revised Operating Standards and/or Corporate policies & procedures. Oversight and Mgmt of Quality Risk Mgmt Processes and for the embedding of QRM principles within the quality framework. Ownership, accountability and provision of Subject Matter Expertise for key quality Systems, including Change Control, NC/CAPA processes, Documentation Mgmt. Responsible for trending programs associated with NC/CAPA, Change Control, Complaints, Periodic Reviews, QRM, ensuring that trend programs and outputs are providing key indicators as to program efficacy. Responsible for challenging current procedures and practices, interpretation of trend data and for making any necessary revisions to quality programs to afford optimisation and further development of existing quality standards and overall compliance. In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role. Basic Qualifications: Basic Qualifications Basic Qualifications • University degree. Engineering or Science related discipline preferred. • Relevant experience (8yrs +) 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: Preferred Qualifications Preferred Qualifications • 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 • Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections. • Experience working in aseptic operations, protein formulation, vial and syringe filling. 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

2023 days ago

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