Jobs at Ge Healthcare in Ireland, Cork

Training Strategy & Governance

• Develop and implement a site-wide training strategy aligned with the sites transformational journey and regulatory expectations.

• Lead the training workstream for audits and inspections, ensuring readiness and documentation compliance.

• Maintain and improve training SOPs, policies, and governance structures.

• You will partner with functional leaders to proactively develop new competencies, ensuring that teams can effectively adapt to evolving business conditions.

Compliance & GMP Training

• Oversee delivery and tracking of GMP, Safety, and Compliance training.

• Ensure training records are audit-ready and aligned with regulatory standards.

• Partner with Quality and Operations for training effectiveness assessment and gap closure.

New Hire & Role-Based Training

• Design and manage onboarding programs for new hires, ensuring timely and effective integration.

• Coordinate role-specific training plans in collaboration with department leads and SMEs.

Leadership & Capability Development

• Support the development and delivery of leadership training programs.

• Partner with external vendors to design and deliver high-impact learning experiences, tailored to the needs of the site transformation roadmap.

• Promote upskilling initiatives for staff.

Learning Systems & Analytics

• Manage the Learning Management System (LMS), ensuring accurate data and reporting.

• Analyze training metrics to ensure inform decision-making and continuous improvement.

• Support training grant administration and reporting in collaboration with IDA Ireland and other relevant bodies.

Qualifications & Experience

• Bachelor’s degree in Life Sciences, HR, Education, or related field

• Strong experience in Learning & Development, preferably in a regulated environment.

• Ability to lead cross-functional teams and manage change initiatives.

• Proven experience managing training programs in GMP-compliant settings and interacting with external regulatory agencies.

• Proficient with LMS platforms and familiar with IDA grants or similar funding.

• Familiarity with IDA training grants or similar funding mechanisms

• Proven experience in leading the design and implementation of site-wide training strategies that align with organizational goals and regulatory requirements.

• Strong knowledge of GMP, regulatory compliance and audit readiness.

• Excellent communication, facilitation, and stakeholder management skills.

• Strong interpersonal and communication skills, with the ability to build relationships and influence at all levels of the organization

• Analytical mindset with experience using data to drive learning outcomes

• Comfortable working in highly regulated, fast-paced environments.

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Lead and maintain core quality systems including CAPA, Change Control, Document Management, Training, Audit Management, and Risk Management.

• Oversee the complaints handling process, ensuring timely investigation, root cause analysis, and implementation of effective corrective and preventive actions.

• Lead the preparation and execution of periodic QMRs, ensuring comprehensive analysis of quality system performance.

• Manage the APR process to ensure timely and accurate review of product quality data and implementation of improvements.

• Ensure the QMS meets all relevant regulatory requirements and support audits and inspections.

• Identify and implement improvements to quality systems to enhance efficiency and compliance.

• Lead and develop a team of quality professionals, fostering a culture of accountability and learning.

• Develop and report on key quality metrics and communicate performance to senior leadership.

• Oversee the quality training program to ensure employees are trained and competent.

• Lead risk assessments and mitigation strategies related to quality systems and compliance.

• Bachelor’s degree in a scientific, engineering, or related discipline (Master’s preferred) or equivalent.

• Strong experience in Quality Assurance or Quality Systems in a regulated industry.

• Solid experience in people leadership, including team development and coaching.

• Strong knowledge of global regulatory requirements and standards

• Proven leadership experience with cross-functional teams.

• Excellent communication, analytical, and problem-solving skills.

• Experience with electronic QMS platforms (e.g., Veeva, TrackWise, MasterControl)

• Lean Six Sigma or similar continuous improvement certification.

• Experience in leading regulatory inspections.

• Ability to influence and drive change in a matrixed organization.

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Manage master planning, material processes and systems, prepare and update production schedules and purchasing needs. Ensure operational alignment with production plan and KPIs. Optimize inventory and process improvements.

• Prepare manufacturing plan that supports the supply timelines required by our customer whilst balancing inventory levels and operational efficency of site assets. Tracks progress, readjusts schedules and communicates changes to affected stakeholders, whilst actively mitigating impact and resolving any product supply and/or customer service issues

• Maintain SAP planning parameters to ensure data integrity

• Maintain and report on relevant Supply Chain KPI’s including plant inventories, backorders, and stockouts.

• Compiles, analyzes and presents non-routine information to support Supply Chain activities and to assist with decision making– e.g. inventory levels, inventory positioning, material deliveries, planned master production schedule, S&OP and sales forecasts

• Develop robust processes that support and enhance the planning function

• Establish and maintain positive working relationships across the Site and Supply Chain. Negotiates and monitors levels of service or performance provided, communicates and actions areas of concern to resolve issues.

• Monitoring stock levels, forecasting demand, and placing orders to ensure timely replenishment.

• Creating and processing purchase orders, tracking shipments, and resolving any issues with deliveries.

• Maintaining positive relationships with suppliers, resolving disputes, and evaluating their performance.

• 3rd level qualification or equivalent work experience in the pharma industry.

Clear and concise written and verbal communication, active listening.

• Teamwork & Collaboration:

Ability to work effectively with others, contribute to team goals, and collaborate on projects.

• Problem-Solving & Critical Thinking:

Identifying issues, analyzing situations, and developing effective solutions.

• Adaptability & Flexibility:

Ability to adjust to changing situations, learn new skills quickly, and embrace new challenges.

• Attention to Detail:

Ensuring accuracy and thoroughness in work, paying close attention to details.

• ERP System Knowledge / Microsoft Excel Proficiency:

Experience with ERP systems required, preferably SAP. Strong Excel skills with an ability to manipulate data.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Develop and execute strategies for Production & Supply Planning, Materials Management, and Distribution, while leading day-to-day activities of the function.

• Develop actions to drive improvement in the effectiveness and efficiency of these teams and their contribution to corporate objectives – with a particular focus on improving the use of digital technologies and leaning processes.

• Key member of the Cork site leadership team – supporting site wide initiatives on Safety, Quality, Delivery and Cost

• Ensure compliance with current regulatory standards (GMP/GDP) and guidelines (Distribution, administrative, financial & quality assurance), including ensuring you and your team complete all the required training

• Work with cross functional teams (Demand Planning, Commercial, Customer Service, Finance) to deliver a best-in-class S&OE and S&OP process. These processes will align site capacity with demand to meet customer requirements

• Manage inventory planning from raw material through finished goods, ensuring inventory is maintained at optimal levels to support customer demand and meet company financial goals.

• Using Lean techniques such as PSR, DMS etc, develop metrics and key performance indicators to proactively identify trends and formulate action plans to drive improvements.

• Ensure that you and your team complete all required training in a timely manner to maintain compliance with GMP/GDP standards and internal procedures, including staying current with updates to company processes, documentation practices, and regulatory expectations.

• Bachelor’s degree in business or supply chain, or equivalent knowledge
• Solid experience within a Supply Chain leadership role - Manufacturing, Planning, Sourcing or Logistics – preferably within a regulated GMP/GDP environment
• Experience in collaboration with the key interfaces within the end-to-end supply chain, with manufacturing and between supply chain and commercial functions
• Extensive knowledge of Lean concepts alongside practical implementation
• Strong knowledge of ERP planning systems.
• Strong leadership skills to influence cross functional and global teams

• Proven to be effective driving outcomes in large, matrixed organizations – understands how to navigate geographies, cultures, relationships, etc. Can drive work around the world because they are accountable, trustworthy, credible, committed, and intellectually agile.

• Excellent communications, influencing and collaboration skills required to manage a multitude of internal and external customers and partners

• Strong external focus on customer

• Strong team player who possesses excellent analytical and communication skills, ability to identify and challenge assumptions, and a strong work ethic

• Must be able to quickly grasp the various dimensions of business issues. Must be able to make sense out of complexity, deal with uncertainty and understand the implications of a decision on all affected parts of the business unit

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Roles and Responsibilities:

• Carry out routine analysis on Finished Product samples ensuring compliance with cGLP/cGMP and that turnaround times are met. The testing carried out includes but is not limited to: HPLC, Osmolality, Organic Iodine, Inorganic Iodine, Thin Layer Chromatography, Free aromatic amines, pH, RI, Trom’s, EDTA, Technical tests, Extractable volume.
• Assisting in the maintenance of the stability program
• Actively involved in Investigations
• Logging of samples in LIMS
• Entering results on LIMS, checking results are within specification and also task approval.
• Always ensure compliance with EHS, actively participate in EHS activities and 5s.
• Perform routine instrument calibration checks at appropriate times.
• Preparation and control of Standard Operating Procedures and always ensuring compliance with cGMP guidelines.
• Completion of Documentation for Batch Release process.
• Assisting in the provision of trends
• Assist in audits.
• Generation/ reporting of Key performance indicators for the group.
• Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.
• Interaction with other departments e.g., QA, BU, Sterility assurance etc.
• Keep colleagues informed of current issues and developments as appropriate.
• Carry out additional duties as deemed necessary by your PTL/Senior Analyst PRINCIPAL QUALIFICATIONS:
• A third level Science Qualification
• SkillsREQUIRED: Good communications skills, excellent time management skills, flexibility and agility will be required. Openness to change. Proven ability to work on own initiative and deliver expectations. DESIRED WORK EXPERIENCE: Pharmaceutical experience in a GMP regulated laboratory environment.

Safety Mindset

• Proactive awareness, regularly assess risks and take preventive measures to mitigate potential hazards.

• Compliance and standards adhere to all safety regulations and ensure team members follow safety protocols.

• Communication, foster open communication about safety concerns and encourage reporting of hazards.

• Training and education, provide ongoing safety training and stay updated on the latest safety practices.

Technical Leadership:

• Lead and mentor a team of engineers, providing guidance and support to ensure successful project delivery.

• Represent operational engineering as the technical lead in large capital projects, ensuring alignment with project goals and objectives.

• Develop and maintain technical standards, best practices, and procedures to ensure consistency and quality across all engineering activities.

Project Management:

• Oversee the planning, execution, and delivery of engineering projects, ensuring they are completed on time and within budget.

• Collaborate with cross-functional teams to define project scope, objectives, and deliverables.

• Monitor project progress, identify risks, and implement mitigation strategies to ensure successful outcomes.

Innovation and Continuous Improvement:

• Drive innovation within the engineering team, encouraging the exploration of new technologies and methodologies.

• Implement continuous improvement initiatives to enhance the efficiency and effectiveness of engineering processes.

• Stay up-to-date with industry trends and advancements, integrating relevant developments into project strategies.

Stakeholder Engagement:

• Build and maintain strong relationships with internal and external stakeholders, including clients, vendors, and regulatory bodies.

• Communicate technical concepts and project updates to non-technical stakeholders in a clear and concise manner.

• Represent the company at industry conferences, seminars, and other events, showcasing our engineering capabilities.

Operational Engineering:

• Lead the operational engineering efforts in large capital projects, ensuring seamless integration of operational requirements into project designs.

• Collaborate with project managers and other technical leads to ensure operational engineering considerations are addressed throughout the project lifecycle.

• Provide technical expertise and support during the commissioning and operational phases of projects.

Process Improvement:

• Perform troubleshooting of issues identified during operations.

• Lead manufacturing investigations, CAPA’s, Change Controls, and ownership of Deviations within the site's Quality System (Trackwise).

• Collate and analyze manufacturing performance data to help focus improvement efforts using tools such as Pareto, FMEA, DOE, 8D, 5-Why, and Root Cause Analysis.

• Provide technical leadership by acting as ‘System Owner’ to drive improvements and excellence within specific aspects of the manufacturing operation.

• Support the manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training.

Validation and Compliance:

• Assist and/or lead facility and equipment validation activities.

• Execute continuous improvement projects within the site's aseptic filling manufacturing areas.

• Develop and/or review URS for process and automation systems. Lead and coordinate equipment vendor FATs ensuring acceptability of plant and documentation prior to site delivery.

• Play a key role in the review, approval, and execution process of Engineering and Validation lifecycle documentation.

• Ensure adherence to standards and good engineering practices.

Investigations and Audits:

• Act as the engineering technical lead during investigations and audits, providing expert guidance and support.

• Lead the preparation and presentation of technical information during internal and external audits.

• Ensure all engineering activities comply with regulatory requirements and internal standards.

• Degree in Chemical Engineering, Process Engineering, or associated discipline or equivalent

• Significant engineering experience in a site and/or corporate engineering environment, with specific specialized expertise in Upstream Processes, Downstream Processes, Oral Solid Dosage, CIP/SIP, Clean Utilities, utilities, HVAC, Packaging, and Devices.

• Ability to read/interpret engineering drawings and design documents.

• Excellent technical writing and verbal communication skills.

• Good technical knowledge of project engineering principles, i.e., all phases of project life cycle - URS through to hand-over.

• Fluent in the needs of validation FAT to PQ (protocol generation, review, execution, and reporting).

• Knowledge of cGMP/GAMP requirements.

• Experience with Six Sigma and Lean Manufacturing methods would be an advantage.

• Proficiency in the use of quality management systems, with experience in the use of Trackwise software being an advantage.

• Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio.

• Strong problem-solving and decision-making skills and attention to detail.

• Strong interpersonal skills and the ability to communicate across functions.

• Ability to manage time independently, tasked with short-term reactionary duties as well as long-term strategic projects.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Roles and Responsibilities:

• Carry out routine analysis in QC Raw Material Team samples ensuring compliance with cGLP/cGMP and that turnaround times are met. The testing carried out is on In coming materials.
• Actively involved in Investigations
• Always ensure compliance with EHS, actively participate in EHS activities and 5s.
• Perform routine instrument calibration checks at appropriate times.
• Preparation and control of Standard Operating Procedures and always ensuring compliance with cGMP guidelines.
• Completion of Documentation for Batch Release process.
• Assisting in the provision of trends
• Assist in audits.
• Generation/ reporting of Key performance indicators for the group.
• Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.
• Interaction with other departments e.g., QA, BU, Sterility assurance etc.
• Keep colleagues informed of current issues and developments as appropriate.
• Reasonable level of overtime will be required to facilitate the business needs.
• Carry out additional duties as deemed necessary by your PTL/Senior Analyst

PRINCIPAL QUALIFICATIONS:

A third level Science Qualification

Good communications skills, excellent time management skills, flexibility and agility will be required. Openness to change. Proven ability to work on own initiative and deliver expectations.

DESIRED WORK EXPERIENCE:

Pharmaceutical experience in a GMP regulated laboratory environment.