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.
Senior Automation Engineer SK biotek is seeking to recruit a Senior Automation Engineer on a contract basis. Reporting to the Automation Lead, key responsibilities of this role will include: Software/Hardware installation and configuration on PLC, SCADA, DCS and PI Historian systems Development and execution of automation design, commissioning and validation testing documentation Automation plant support, including, if deemed necessary, the provision of 24hr plant support Problem determination, recording and analysis of Automation problems, to help prevent reoccurrence Provision of training and support to appropriate personnel/departments in the early detection and resolution of issues Ensure successful delivery of automation projects and automation aspects of projects in order to meet business needs in a cost effective and efficient manner and in compliance with site standards and procedures. Developing and maintaining collaborative relationships with stakeholders. Implementation, control and maintenance of security access to automation systems, Implementation, management and maintenance of backup, archiving and restore of GMP data from automation systems Adherence to the GAMP 5 Guidelines and Computer System Validation Policy, internal, external audit requirements and company policies Contributing to the overall success of the department by working with fellow team members and other department groups to ensure that a quality automation support service and project service is provided. Required Qualifications and Skills: The ideal candidate will also have: Knowledge of SCADA / PLC, DCS networks and associated hardware & software, particularly DeltaV, and experience of working with and troubleshooting automation systems Knowledge of Windows / Microsoft Administration. Experience in Virtualisation is an advantage Good working knowledge of the Process Automation / I.T industry standards and frameworks A proven track record of compliance in a GMP environment Strong interpersonal, organisational and communication skills The ability to consistently meet deadlines. Interested applicants can click 'Apply' or call Dominic on 01-6455254 for further info.
The Company My client is a leading software and services provider to the broader London insurance market. It was founded in 2008 and has since grown to become one of the leading insurance software specialists in the London Insurance Market. You will join as a key member of the development team, you will use your creativity to develop unique software solutions. You will be involved in the full development life cycle including the analysis, design, planning, implementation and maintenance of our software solutions and will work as part of a team to achieve this. My client aspires to be a market leader in the technology sector and is always looking for new ways to approach projects or improve existing content. We look to hire people that will help us achieve this with hard work, enthusiasm and a demonstration of their experience and expression of their own ideas. Role Description As a key member of the Software Testing team, this role requires a strong software testing background, being detail driven, and excellent problem-solving abilities. The successful candidate will be responsible for the thorough execution of test cases and exceptional attention to detail while in a fast-paced Agile environment. The Software Test Engineer will be working to implement new solutions for the London and Global Insurance Markets. Responsibilities All aspects of testing from test design to test execution Preparing schedules with target dates for test deliverables Proactively communicating with development teams and business analysts to resolve issues or questions pertaining to test execution Disciplined tracking, reporting, and resolution of product defects Accurate and timely status reporting to Management, including issues prohibiting progress when appropriate Elevating critical risks to project, management and senior-executive teams Expanding existing test libraries, building and maintaining modular, end-to end and automated regression tests that can be leveraged across projects Re-testing defect fixes and regression testing Ensuring business receives working software that supports the business requirements according to the project scope outlined in the BRD Requirements A minimum of 2 years software testing experience on complex IT projects Degree in computing, engineering or science subject area Experience in test case development and execution A deep understanding of software testing best practices and drivers for change Experience of testing web-based applications An ability to work on more than one project at a time Experience of Windows environments Strong documentation skills Knowledge of scripting languages Requirements Analysis experience Test Automation experience Selenium Web Browser Automation PLEASE NOTE: Candidates must have full working rights in Ireland i.e. a current Stamp 4 Visa or an EU Passport to be eligible to work in Ireland 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.
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!