Key responsibilities will include:
Associate Manager - MES Operations Summary The Associate MES Manager is responsible for the management of the Manufacturing Execution Systems on site, the integrity of the data housed therein and the associated data exchanges - an exciting time to be involved in a number of key MES projects on site. This role is also responsible for ensuring that MES fully meets the needs of the business by aligning with Clinical and Commercial leadership and that associated policies and processes are effectively implemented and maintained. This role provides leadership, support and guidance to the MES support team to ensure that the business' needs are met with daily support and maintenance. Key Responsibilities Coordinate the needs of functional groups and establish the priorities for MES requirements, system design and implementation and assign appropriate project to group. Conduct requirement and design session with users as needed for continuous process improvement Review company documentation including SOPs, requirements and Manufacturing Batch Records to assess MES impact Develop strong business relationships with Clinical and Commercial groups to attain a solid understanding of their goals and objectives for better support with MES capabilities. Develop strong business relationships with Quality Assurance and Material Management for an understanding of their goals and objectives for alignment with MES capabilities Develop a strong business relationship with Information Technology to cultivate a solid understanding of roles and responsibilities with MES implementation and maintenance Align MES Support team's business practices with Clinical and Commercial objectives to pro-actively anticipate future needs and create solutions to address them Assume responsibility for maintenance including all future upgrades, enhancements and validations as needed and approved by senior management. Work with system vendor to guarantee MES is up to date and can easily meet current and future business needs. Actively drive process improvement initiatives as appropriate. Provide system performance and usage metrics as required. Collaborate with appropriate Training groups to develop and schedule training sessions that best serve the business needs Provide MES team members with guidance and support to ensure that they have the skills and tools required to consistently support business needs and individual professional goals. Support multiple instances of MES throughout the IOPS organization Review and approve MES Change Controls Ensure GxP compliance Respond to audit inquiries Education/Experience BA/BS in engineering, biological or physical science, computer science, or information technology required. A minimum of 6 years of relevant experience including 2 years of experience working with MES or manufacturing systems within a life science manufacturing environment MES system configuration experience Experience in programming automation systems (DCS) and SQL preferred Key Competencies Familiarity with technologies used throughout MES Process (i.e. Interfaces, Level 2, Integration and Infrastructure), MES recipe configuration, MES workflow, SQL, Oracle and relational database concepts Knowledge of Werum PAS|X Knowledge of integration of MES systems with ERP and Shop Floor systems Interested? Call Jack on 01-6455250 for more information or click apply below!
QA Manager A QA Manager is required to join a leading Pharmaceutical company based in North Dublin. This position offers an impressive and unique opportunity for interested candidates and requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations. This role will be responsible for providing compliance leadership ensuring the site operates to the applicable cGMP and international standards for their customers on a daily basis, as well as a number of critical responsibilities across the site. This is a great opportunity to join a select team that has quickly established itself leading the way in the Pharmaceutical industry in Ireland. Reporting Structure - Quality Director Key Responsibilities Manage quality aspects of GMP computerized systems and the supporting infrastructure used on site to ensure compliance with company policies, procedures and regulatory expectations. Mentor and coach a highly skilled, professional team to ensure that validation activities are completed in line with cGMP and international standards. Review and approve the GMP design aspects of major capital projects including new facility construction, facilities upgrade, new manufacturing equipment and support systems. Ensure that all Equipment and Computer Systems are validated to the required cGMP standards and are maintained in a validated status. Coordinate and participate in review and approval of change controls, SOPs, reports and other documentation, review and approval of master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria Support customer and regulatory inspections Drive the development and implementation of new techniques, systems and initiatives to enhance the quality system on site. Champion continuous improvement with particular focus on right first time and lean methodologies Develop and deliver training with regard to compliance based on business needs. Manage key elements of the quality management system including document management process, internal audit process and change control process Partner with QA Operations team to ensure that in promoting a culture of Compliance, Right First Time and Continuous Improvement. Education A minimum of a Bachelor's Degree in Science, Engineering or similar technical discipline. Advanced qualifications are desirable and at least 10 years' experience in the Pharmaceutical industry. Core Competencies Strong Quality and People Management skills Strong understanding of the key business drivers of the industry/organization. Excellent communication and organisational skills with demonstrated expertise in effectively communicating with all levels of the organisation are required. Candidates should be able to demonstrate an ability to lead cross-functional teams and to make decisions in pressurised situations to ensure compliance. Interested? For more information on this, and other suitable roles, please contact Jack on 01-6455250, or email your CV to jack.conway-kenny AT experis.ie
Software Test Engineer Kildare 12 Month Contract (Strong possibility of extension) Neg. Daily Rate Responsibilities Drive manual testing, integration testing, user journey automation, cross device/browser automation for web applications, release sign-offs, crowd sourced testing, etc. Coordinate and participate in requirements review/story elaborations and testing activities to deliver high quality products and incremental value with every iteration. Develop test scripts and perform automated and manual exploratory testing to ensure software meets business and security requirements and established practices. Requirements Should have excellent analytical skills. Should have good experience in Functional/Manual testing. Experience in both Unit and Integration testing needs. Experience testing across a variety of platforms: web and mobile user interface, APIs (REST and SOAP), and/or data warehouse reports. Ability to create good acceptance and integration test automation scripts and integrate with Continuous integration (Jenkins/Bamboo) and code coverage tools (Sonar, Clover). Exposure to Continuous integration and delivery concepts desirable. Good to have experience on automation tools Good verbal and written communication skills Good experience working in Agile/Scrum teams PLEASE NOTE: Candidates must have an EU Passport or Stamp 4 Visa to be considered for the role. For more information or to apply to the role contact Emmet on 01 6455250 or email to emmet.mceneaney AT experis.ie.
Business Systems Analyst Cork or Dublin 6 Month Contract Max €300 per day Description The Business Systems Analyst plays a key role as subject matter expert and technical consultant throughout the lifecycle of assigned applications used by Business Units and Administrative functions. Business Systems Analysts are responsible for supporting the end to end implementation of projects and solutions from analysing and documenting business requirements, preparing solution proposals, translating requirements into functional specifications, supporting build deliverables, planning and performing test activities, providing end user training and creating end user documentation, through to deployment, stabilization and steady state support. The Business Systems Analyst will possess a unique blend of technical, business, and people skills. Responsibilities Document and design current and future IT enabled solutions and drive all relevant business analysis to ensure the most effective recommendations are made for successful solution and project plan completion. Exceptional interpersonal skills and written communication skills to frequently interact with all levels of the organization; Ability to interpret technical documentation to meet business needs. Correctly identifies system /functional interdependencies. Demonstrates ability to effectively work both independently and within cross functional project teams. Accurately translating Business Requirements into system functionality requirements. High aptitude for interpreting technical documentation as well as authoring or updating documents as needed (Functional Designs, Business Process Designs). Seen as a cross functional process and subject matter expert. Extensive experience interpreting user needs and writing or editing functional specifications for new systems, systems changes and / or system enhancements; Has the ability to present ideas in a focused and concise manner. Ability to create compelling business justification for recommended direction and design. Creates and executes complex test scripts, provides training to end users and responds to critical production support requests. Essential Requirements Bachelor's degree or master's degree in Computer Science, Information Systems, Business Or equivalent work experience. 7 or more years of relevant technical and business work experience. Understanding of business analysis principles, processes, and techniques Requires leadership skills, experience/in-depth knowledge of business operations and systems requirements processes. Expert knowledge on Microsoft office suite. Desirable Requirements Business analyst certification. Tableau or other Business intelligence tool experience. PLEASE NOTE: Candidates must have an EU Passport or Stamp 4 Visa to be considered for the role. For more information or to apply to the role contact Emmet on 01 6455250 or email to emmet.mceneaney AT experis.ie.