Location: Commutable from Co. Louth, Meath, Monaghan, Cavan and Down.
We are now recruiting for an Engineering leader to provide engineering direction and support to the value stream. The key role is to manage all engineering support activities within the value stream ensuring goals and targets are met within agreed time, cost, quality, health and safety, attendance and environmental parameters utilizing Lean manufacturing principles and tools.
Associate Supply Chain Director
Location: Dublin
Industry: Pharmaceuticals
Minimum Requirements
- Extensive experience working in Supply Chain processes, including multi-level planning.
- Bachelor's degree in supply chain, business administration or a related discipline.
- Some understanding of and exposure to manufacturing of biopharmaceuticals
- Thorough understanding of cold chain distribution.
- Hands-on experience of product launches and launch process.
- Familiarity with quality systems and proven knowledge of cGMP and cGDP.
- Interpersonal skills and professional skills to interact with external personnel while representing my client.
- Must communicate effectively.
- Prioritize and multitask in an environment with changing priorities.
- Read, write and speak English fluently as well as communicate effectively in various other languages
- Ability to travel up to 30%.
- A people manager, capable of motivating and guiding staff.
The primary purpose of the role is be responsible for the coordination of regulatory submissions from my client for commercial drug substances registered worldwide as assigned by the Regulatory Compliance Manager.
Main duties include but are not limited to:
· Implement the regulatory strategy for complex submissions as defined by the Regulatory Compliance Manager
· Preparation and revision of module 2.3.S and 3.2.S CTD ready for submission sections for the commercial drub substances in compliance with eCTD requirements.
· Develop a regulatory strategy for minor/routine submissions
· Preparation of US and CA Annual Reports for submission within the provided deadlines.
· Maintain an excellent working relationship with Group Regulatory Affairs (GRA)
· Writing regulatory justifications for variations application forms
· Review technical documentation for completeness and accuracy to both internal procedures and source data where required to support a regulatory submission.
· Manage the Regulatory requests spreadsheet and ensure that all Regulatory requests received are completed on-time.
· Manage all requests for legalisation of certificates efficiently
· Perform a review of change controls with potential regulatory impact as required and document and communicate any regulatory impact
· Manage the complete 3.2.S submission tracking sheets for each commercial drug substance, according to its formulation, ensuring that they are updated following regulatory approvals and response to questions
· Responsible for ensuring that a current Intercontinental dossier for each commercial drug substance (2.3.S. and 3.2.S) has the latest variations incorporated and is available and ready for submission in emerging markets.
· Support the maintenance of the Site Master file and associated documents as required.
· Actively participate in Global CMC-Regulatory initiatives as required.
· Actively support and participate in site Quality initiatives and Quality systems as required.
Our Client based in Co Meath have an excellent opportunity for a Cost/Management Accountant to join their organisation. This is a new role within the organisation with opportunity for growth and development
Role
· Preparation of KPI's and weekly/monthly business reports;
· Product and process costing;
· Inventory Management;
· Budgeting;
· R&D reporting for grant and tax purposes
· Internal Audits.
The ideal candidate will have Engineering / Material Science / Packaging degree with an minimum of 5 years experience working with in a related area in high volume manufacturing industry. Operational excellent experience required.
HR Manager required for leading multinational company based in West Dublin
Reporting to the HR Director, this role will have a mix of strategic and operational HR support to the Business.
The HR Manager is involved closely with line management up to and including senior management to provide HR consulting on employee relations, employee & management development, hiring selections, compensation, workplace effectiveness and performance management. Along with line generalist support, the HR manager will provide input to, and have ability and experience in, leading the development and implementation of strategic HR projects and programs designed to create a high performing workplace.
This HR Manager must be an expert in his/her profession and must be comfortable acting as a change agent for a dynamic and evolving technology organization. Ideally will have experience working within multinational fast paced environments.
COMPONENTS ENGINEERING MANAGER required by CareerWise Recruitment for our client based in Dublin to be responsible for leading and directing engineering design and development activities for the components sector of excellence which includes high pressure fuel valves, components, and systems.
My client is looking for a Senior BA to lead the business going forward. You will be involved in identifying, defining and delivering business improvement opportunities through analysis and critical reasoning.
My client is looking for a senior manager / consultant to head up their analytics department. My client is one of the leading providers of management consulting services worldwide, and they arelooking to expand their presence her in Ireland.
Specifially this person will be responsible for supporting clients who seek to develop their predictive capabilities and to integrate the business value of predictive analytics into the fabric of business decision making in order to improve their business.
An Infrastructure Project Manager is required to play a key role in the management of a wide range of client projects focused on infrastructure. Interested applications should have experience managing multiple mid to large projects concurrently and ideally in dispersed locations. This is an excellent opportunity to be involved in a projects covering a wide range of technologies.
