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!
Project Document Controller Summary An experienced Document Controller is required as part of a 6-month contract due to a critical expansion project on site in Swords. The candidate will be required to have meticulous attention to detail, excellent communication skills, and the ability to work independently as well as cross functionally with a number of teams involved in the project. Although not limited to, the key responsibility of this position will be working with SME's to create and edit documentation for the expansion project and manage both the control and approval of the associated documents. Key Responsibilities Day-to-day responsibilities are focused on the control and tracking of documents. Specifically, you'll number documents and input technical revisions, perform compliance checking, filing and organizing, documentation auditing, and report on document status and distribute documents as required. Manage Operations/Operational Duties Frontline enforcement of approved document control procedures across the project organisation and interface with other project participants and team members Maintenance of the document database and associated project documents Undertakes periodic reconciliation of all batch records Prepares and issues logbooks to departments Review of SOP's, forms, etc for compliance with documentation templates Main contact for archival and retrieval for all GMP documentation for site Ensure completed GMP records are filed and archived as per procedures Writes procedures relevant to documentation management systems and document control. Administrative activities to support Regulatory requirements for provision of declarations and obtaining certs Manages information/Provide information Compiles monthly Periodic Review data for metrics and review at monthly Quality Council meetings Provides training on Document Management systems and procedures. Manages documentation trackers with respect to Batch Record issue and reconciliation Manage People/Interactions with People Liaise with all departments to ensure that documents are controlled consistently Provides training to staff from different functions on document management procedures as required Communicates document issues Communicates status of documents when requested Education/Experience Technical qualification in Science or Engineering or qualification appropriate to the position A minimum of 1 years-experience within a documentation management role of a pharmaceutical operation Experience with DCA/SAP/Trackwise preferred Working knowledge of GMP and compliance pertaining to GMP and EHS Excellent PC skills, MS Word, Excel, Powerpoint, Email and Calendar Proven ability to multi-task and work to tight deadlines Exposure or previous project management experience a distinct advantage Ability to consistently meet multiple and often conflicting deadlines. Strong written and verbal communication skills Self-starter and strong attention to detail and proven ability to produce results on strict deadlines If you are interested please click 'Apply' or contact Dominic on 01-645-5254 for further info.
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
Bioassay Specialist This Bioassay Senior role is a critically important activity to ensure efficient and effective compliant design, construction, qualification, and operation of a new strategic facility. This tremendous opportunity will be responsible for qualifying the Bioassay analytical lab and the transfer of Bioassay analytical methods. Additional development opportunities within the micro and chemistry lab will be strongly considered to recognize the tremendous value of knowledge / experience gained by the candidate during the project phases. To maximize the development opportunity, the candidate will be the key leading talent in analytical Bioassay techniques and developing the flow of testing through the lab, to ensure the lab will be best in class across our industry, a benchmark for others to aspire to. The candidate will support the complete analytical lab build. The facility will utilize the latest innovations in technology and automation and latest in analytical techniques. Together, the team will build the future of biologics through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team. The full analytical scope will incorporate micro, chemistry, bioassay, raw materials, stability and in-process). Innovation and advanced analytical methods (rapid ID technics, paperless lab, etc) will allow the candidate challenge current thinking in designing for the future. The candidate will have responsibilities in analytical transfer and qualification of methods. Key Responsibilities Perform activities for general lab readiness, laboratory equipment qualification and method transfers. Strong knowledge and experience of Bioassay methods. Perform and carry out a variety of analytical techniques including but not limited to Potency Elisa test in compliance with GMP requirements. Follow up-to-date analytical practices with reference specifications, regulations and industry standards. Plan and maintain the laboratory testing schedule to achieve an efficient QC system. Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures. Ensure training is current for all job functions performed. Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations. Delivery of area performance to meet or exceed performance or quality goals. Promote and participate the implementation and maintenance of the relevant safety programmes. Participate and Comply with Quality Management System requirements. Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools. Assist in the "operationalising" of the lab with a strong focus on MPS. Train and help develop other analyst within the lab. The candidate will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role. Qualifications Degree qualification (Science/Quality/Technical). Master preferred. Desirable evidence of Continuous Professional Development. Preference Lean Six Sigma Key Experience 3-5 years industry experience with significant knowledge and experience in working in a Bioassay lab unit and working with contract labs Experience in Potency Elisa method Working knowledge of QC Systems (EN, LIMS) and Trackwise Interested? Call Jack on 01-6455250 for more information or click apply below!
AWS Architect The AWS architect role requires a strong solutions-focused approach whilst maintaining and developing collaborative relationships between my client and a key business. You will need to intimately understand the business partners core technical solution environments and requirements as well as being able to define technology solutions and services to solve client initiatives and needs in a challenging technical environment. The candidate should be comfortable to develop and lead technology initiatives and requirements through workshops and/or assessments in order to influence and drive architectural and solution designs as well as developing and refining repeatable methodologies that are client deliverables led and quality driven. Essential duties and responsibilities will include: Assisting and guiding key technical stakeholders through business, information, process and technology changes in order to meet strategic delivery objectives and solution deliverables Supporting complex, consultative technical processes including solution definition, proposal development and design Engaging as adviser to influence and direct through cultivating mutual respect; performs in a technology leader role due to breadth of knowledge in cloud technology service offerings and transformation Provides expertise and creative approaches on aligning current trends in technology whilst understanding and considering existing business and technical constraints Understands many disciplines including: application architecture, middleware platforms, resiliency and DR, databases, virtualization, servers, storage, and cloud computing, along with understanding of technology and industry trends Experience: 10 years' integration and delivery experience in IT with multi-discipline experience in complex project deliverables 5-7 years' experience in IT consulting leading complex solutions and projects Experience in IT architecture design and implementation to maximize support of building cloud compatible services and cloud-based environments Demonstrated experience building and managing IT solutions and integrating Cloud technologies Hands on architecture experience with a proven track-record in implementing large scale cloud environments, cloud computing-based services architectures, technical design and implementations Comprehensive knowledge of hardware, software, application-types, and systems engineering Minimum 7+ years designing and managing Public/Private cloud infrastructures using Amazon Web Services (AWS) (including EC2, S3, Cloud Front, Elastic File System, RDS, VPC, Direct Connect, Cloud Watch, Cloud Trail, Cloud Formation, Red shift, EMR and IAM) Hands on experience with AWS and operation expertise. Experience in one or more automation languages (CLI, Python, Ruby, PowerShell). Hands on experience with CloudFormation templates and Terraform. Working knowledge of config management tools (Packer & Ansible). Knowledge of Public Cloud connectivity solutions such as Direct Connect, VPN and other (Private Link etc.) Thorough understanding of infrastructure automation, CI/CD, networking, storage and cloud-based delivery models. Knowledge in networking and web standards such as DNS, DHCP, TCP/IP, HTTP, web security & firewalls. Experience in autoscaling, load balancing and DR cloud computing models. Experience of DevOps with AWS CLI and/or Lambda services. Knowledge in cloud monitoring tools, application performance monitoring tools and operational dashboarding You must have: Ability to explain complex technical issues in a simplistic manner Ability to influence architectural and solution designs and decisions by understanding and communicating how proposed solutions will solve business needs, requirements and problems. Fluency in formulating and expressing thoughts and ideas. Outstanding oral, written, and technical/business communication skills. Strong technical and customer interaction skills. Ability to multi-task and accommodate requests from multiple teams and pillars For more information on this or other roles feel free to contact Alison on 01 6455250 or alison.byrne @ experis.ie