PE Global | Senior QA Specialist | dunboyne

4 days ago

Dunboyne Co Meath, Ireland PE Global Full time

The role: PE Global is currently recruiting for a Senior QA Operations Specialist on behalf of a leading pharmaceutical company based in Meath. This is an initial 11-month contract role. Description: The QA Operations role will lead Quality Assurance activities at the BioNX, Research & Development Division facility. The role is a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations. The role will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations. The Quality Assurance Operations, BioNX (Contractor) will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required. Responsibilities: Lead, facilitate and participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones. Participate in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility. Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility. Complete QA operational duties related to product disposition including in-coming material release and the performance of detailed review of eBR prior to QP release. Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required. Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required. Assist in the creation and maintenance of QA policies, SOPs and reports in line with site requirements. Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements. Participate in and support risk management activities in line with relevant guidance and best industry practice. Assist in the execution of the internal audit programme including the performance of audits are required. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture. Ensures the escalation of compliance risks to management in a timely manner. Education and Experience: Degree qualification (Science/Quality/Technical). 8-10 years experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry. Project Manager capability with significant understanding of Operations. Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME. Strong written and verbal communication skills. Ability to think logically and be proactive under pressure. Ability to work as part of a team and on own initiative in a constructive manner. Strong attention to detail and precision in preparing and reviewing GMP documentation. Experience in quality management systems such as Veeva, SAP, PAS-X etc. Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals. Experience in direct interactions with regulatory agencies during site inspections. Interested candidates should submit an updated CV. Please click the link below to apply, call Audrey on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** 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. Skills: quality assurance GMP operations CAPA

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