QA SPECIALIST- PHARMACEUTICALS- MIDLANDS. Job purpose: The successful candidate will be responsible for ensuring that the process for the manufacture of drug product is in compliance with cGMP and the associated regulatory requirements and also for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations. Key Responsibilities: Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems. Review and approval of change controls, SOP's, Deviations, cleaning verification/validation data and other documents as necessary for the IPT department. Provide feedback to IPT teams via RFT metrics and real time review to drive improvement in GDP and documentation quality performance. 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. Support the development and implementation of improved quality reporting measures. Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing. Work shift patterns in line with manufacturing operations to ensure Quality oversight as required. Provide effective real time on the floor support for day to day manufacturing operations for example area clearances, batch record reviews, aseptic operations. Provide quality input into decision making process on the shopfloor ensuring that product quality is maintained. Provide training in all aspects of Quality Management Systems and GMP. Ensure all work is carried out in line with SOPs, training or other quality systems such as change. controls where applicable. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. 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 Microbiology Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives. Drive compliance with 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. 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. Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions using the site SAP system as a tool. Participate and provide quality input in root cause analysis of system failures and substandard. performance (equipment and personnel), using standard tools and methods, to resolve. Participate in initiatives supporting root cause elimination to improve performance at site. 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, audit/inspection duties, investigations, batch work, customer queries etc.; thereby ensuring IPT is audit/inspection ready. Conduct area inspections for IPT as appropriate. Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same. Such ongoing monitoring/metrics gathering may include: Monitoring of quality systems, The self inspection program, Verification of the effective implementation of key GMP programs. Effectiveness of Preventative Actions. Educational and additional requirements: Bachelors Degree or higher preferred; ideally in a related Science discipline. Ideally 1-2 years experience in pharmaceutical manufacturing environment preferably in a quality role. Working knowledge of regulatory/code requirements to Irish, European and International. Codes, Standards and Practice. Knowledge of cGMP and GDP essential. Report, standards, policy writing skills required. Competent in the use of MES, SAP and Trackwise. Knowledge of aseptic filling processes and equipment is desirable. Proficiency in Microsoft Office and job related computer applications required. Morgan McKinley is acting as an Employment Agency in relation to this vacancy. Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide. This job originally appeared on RecruitIreland.com.
274 days ago