Cache of job #13890289

Job Title

QA Specialist

Employer

Fastnet The Talent Group

Location

Carlow

Description

The QA Specialist (NPI / DS / Materials) 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, including: 1. Ensuring that the process for the introduction of biologics/vaccines is in compliance with cGMP and the associated regulatory requirements. 2. Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing. The role reports to the Associate Director of Quality and who will liaise with cross functional teams on site, in particular Supply Chain, Technical Engineering and Operations to ensure manufacturing, technical and regulatory requirements are met. Responsibilities: * Provide quality oversight and direction for the introduction of new products, drug substance and materials 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 and materials. * Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities. * 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, drug substance and material introduction (Material Packs, QC Test Specifications, BOMs, MES documentation etc.) * Provide quality oversight and direction for Material introduction process and external party management. * Development & monitoring of supplier performance metrics. Actively participates as a member of Material Review Board and Quarterly Business Review of key suppliers, and other cross functional forums as requested. * Maintain the approved supplier management list within the qualified Supplier Management system by ensuring that all suppliers and materials used are correctly set up. * Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions. * 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. Minimum Education: * Bachelors Degree or higher preferred; ideally in a related Science discipline. * 3-5 years experience in a quality role, ideally in a pharmaceutical manufacturing environments. * 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. Initial Travel Requirements: * Only very occasional travel may be required. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.

Date Added

2163 days ago

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