QA Specialist - Carlow
PE Global is currently recruiting for a Quality Assurance Specialist for a Client site in Carlow - The Quality Assurance Specialist role supports the introduction and execution of new products and drug substance into the Carlow facility. The QA Specialist (NPI and DS) will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities. Responsible include: Ensuring that the process for the introduction of biologics/vaccines is in compliance with cGMP and the associated regulatory requirements. Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing. Ensure that objectives are effectively achieved, consistent with clients requirements to ensure compliance, safety and reliable supply to our customers. Principal Accountabilities: Provide quality oversight and direction for the introduction of new products and drug substance onto site covering the end to end strategy. Quality point of contact at both a site level and for all external inputs (Transfer Site QA/QC/ Regulatory), including co-ordination of/attendance at Quality working group meetings. Participate as functional expert in the cross functional team that manages introduction of products onsite. Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities. Facilitate batch release strategy between supply, manufacturing and packaging sites. Authors, reviews and participates in approvals of protocols and reports for technology transfer, method qualifications and method validation. Review other documentation associated with new product and material introduction (Material Packs, QC Test Specifications, BOMs, MES documentation etc.) Provide quality oversight for the receipt and approval for use of Drug Substance. Liaise effectively with the DS manufacturing site / external support team to ensure that batch related queries are responded to in a timely manner to support batch disposition. Review DS packs, including sending site data, testing results, deviations, change controls in advance of QP disposition. Support the development and implementation of improved quality reporting measures. Aid the effective implementation of the Quality Management System, and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends. Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site. Actively participate in Plant/Quality committees and works with other site functional groups, such as the QC, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives. Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions. Preparation of Product Specification Files for new products. Partner with colleagues cross functionally to provide support and advice on day to day basis and on a project basis including communications, training, project work, investigations, batch work, customer queries. Review and verify site documentation that may be used for submission to CMC or other requester(s) for regulatory submissions/filings. Assure the accuracy and integrity of all data and information through a timely review program. Support the review of all batch related documentation. Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same. Ensure reliability and performance by facilitating effective systems for identification of root cause failures, recommendations and implementation of improvement changes throughout processes, ensuring calibrations of equipment are performed as necessary. Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action through the change management system. Drive compliance with clients Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned. . Skills & Knowledge: Typical Minimum Education. Bachelor’s Degree or higher preferred; ideally in a related Science discipline. Typical Minimum Experience. Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting. Core Competencies: Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Knowledge of cGMP and GDP preferred. Report, standards, policy writing skills required. Equipment and process validation. Sterile filling processes and equipment. Proficiency in Microsoft Office and job related computer applications required. Lean Six Sigma Methodology experience desired. Interested candidates should submit an updated CV, marked for the attention of Audrey email@example.com or 00353 21 4297900. This job originally appeared on RecruitIreland.com.
373 days ago