Associate Specialist Quality Control

IrishJobs

Carlow, Carlow, Ireland

Carlow, Carlow, Ireland

Jetzt Bewerben

Über

Associate Specialist Quality Control We are seeking anAssociate Specialist Quality Control to provide technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan. This role is integral to our manufacturing division and requires a high level of leadership, initiative, collaboration, and coaching to facilitate the team in becoming a high-performance organization. If you are passionate about driving continuous improvement and delivering technical excellence, we invite you to join our company and make a difference in advancing health solutions. Experience in supporting operations projects with knowledge of regulatory and global compliance requirements. The ideal candidate must have the ability to own and manage projects and deliver on required timelines. Key Responsibilities Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures. Supporting and owner of Environmental monitoring risk assessments and qualification. Generation of quarterly and annual trend reports. Understanding and applying regulatory/compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes. Development and execution of Microbiology test methods and project validations. Troubleshooting of issues which arise during the execution of validation studies and routine tests. Development of training modules. Microbiology Support to Site Investigations and projects relating to environmental monitoring and utilities monitoring. Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment. Authoring and managing change controls, procedures, test methods and deviations. Result authorization for microbiological samples to support batch release. GLIMS System updates. Assessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control. Supporting lab stock management and financial control as required. Interpreting customer needs, assessing requirements, and identifying solutions to non-standard requests. Making decisions within guidelines and policies which impact microbiology projects. Ensuring highest safety standards. Performing other duties as assigned. Qualifications Required Bachelor's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or a related Life Sciences field. Minimum 3 years of hands-on experience in microbiology/QC, specifically in environmental monitoring and utilities monitoring, supporting site projects, trending, risk assessments, and data analysis. Ability to author procedures, change controls, deviations, reports, and work in line with regulatory/compendial requirements. Strong troubleshooting, decision-making, and ability to drive improvements such as lean lab initiatives and method optimization. Strong microbiology background and strong understanding of aseptic processing, environmental monitoring programs, and contamination control in sterile manufacturing. Experience in a GMP QC laboratory with knowledge of regulatory expectations. Familiarity with ALCOA(+) data integrity principles, electronic laboratory systems, and controlled documentation. Entry- to early-career level with growing technical competence; able to perform routine tasks with limited discretion. Preferred Experience with problem solving, decision making, scheduling of laboratory testing/tasks

TLNT1_IJ

Carlow, Carlow, Ireland

Sprachkenntnisse

English

Hinweis für Nutzer

Dieses Stellenangebot stammt von einer Partnerplattform von TieTalent. Klick auf „Jetzt Bewerben”, um deine Bewerbung direkt auf deren Website einzureichen.

Jetzt Bewerben