דרושים Environmental Safety Specialist ב-Ge Healthcare ב-Ireland, Cork

• Provide quality assurance oversight on all X Ray & MRI products manufactured by GEHC, Cork covering all stages of product lifecycle i.e. preparation, manufacture, testing, packaging, labelling, storage, transportation, distribution, complaint handling, documentation and record keeping.

• Work with other internal support functions to ensure all processes are designed, implemented and maintained to meet relevant requirements.

• Manage the batch record review and final QP disposition of manufactured batches as per Annex 16 release requirements.

• Review complaints as required related to GEHC Cork and take appropriate action to prevent recurrence.

• Involvement in regular audits to assess the effectiveness of quality systems, identify any non-conformances and recommend corrective actions.

• Maintain accurate records of all quality assurance activities.

• Coordinate the conduct of investigations into quality issues identified through internal or external sources.

• Collaborate with distributors and customers on quality matters.

• Actively participate in cross functional investigations/projects as required.

• Ensure timely communication and reporting to senior management regarding significant product quality issues.

• Bachelor’s degree (2.1 or above) in a relevant discipline such as: Pharmacy, Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry and Technology, Biology or equivalent

• Strong experience in a Quality Assurance role within a Life Sciences industry.

• Strong knowledge of cGMP requirements, EU Directives & Regulations 2001/83/EC, Eurdralex Volume 4, specifically focusing on Annex 13 & Annex 16 requirements .

• Advanced computer skills, particularly Microsoft Office Suite, Excel. Familiarity with validated quality systems e.g. Trackwise Digital, Veeva Vault and Compliance Wire a bonus.

• Proficiency in written and spoken English language essential.

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.

• Implement the EHS Framework 3.0, working in partnership with the leadership team and element owners to support compliance, manage complex issues, lead long-term EHS planning, and support the overall site strategy.

• Implement programs, tools, and training to assist the site in ensuring compliance with legal requirements, implementing GE EHS programs, meeting business expectations and ensuring continuous improvement.

• Analyze and communicate performance against expectations, provide feedback, establish and track required actions to improve the EHS environmental programs.

• Sustain a world class EHS program and safety culture; ensure robust pipeline and process for driving excellence in the workplace (Pollution Prevention, Waste Management, Chemical Management, etc).

• Build, retain and analyze data for process efficiency (Waste, Water, Air).

• Provide technical support and guidance to site projects.

• Manage legal requirements as required.

• Ensure that you are fully aware of, and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

• Complete all planned Quality & Compliance training within the defined deadlines

• Identify and report any quality or compliance concerns and take immediate corrective action as required

• Work with Quality to support QMS initiatives.

• Bachelor’s Degree or Higher Qualification in Occupational Safety, Health, Environment, Engineering, Chemistry degree or equivalent.

• Basic experience with proven EHS knowledge and background in a pharmaceutical, or manufacturing environment.

• Strong interpersonal and communications skills.

• Ability to work in a matrix environment, influence and motivate colleagues to achieve a unified goal.

• Working knowledge of EHS management system would be advantageous

• Skill sets and experience in Industry related Environmental subjects, such as Air and Water Pollution Prevention, Hazardous and Non-Hazardous Waste Management, Chemical Management legislation, etc are desirable.

• Ability to simultaneously manage multiple projects and other responsibilities, adjust to changing priorities.

• Knowledge of European, National & Local regulations, codes & standards, reinforced by a solid understanding of healthcare industry and EHS standards.

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

• Act as a technical and compliance liaison between QC functional teams and Operations/Engineering/QA.

• Provide technical support on QC instrumentation and product testing issue within the QC unit.

• Respond actively and troubleshoot test/instrument performance issues as notified by Operations/Engineering/QA.

• Technical expert in a wide range of chemical and microbiological equipment.

• Familiar with 21 CFR part 11 and how it applies to laboratory instrumentation.

• Sourcing, purchase and qualification of laboratory equipment.

• Carry method validation activities, through writing and executing protocol.

• Research new technologies to improve laboratory compliance and efficiency.

• Ownership of quality systems actions (IR's,CAPA,CC) ensuring timely closure and performance trending.

• Degree in Chemistry/ Microbiology, or in a science subject.

• Basic pharmaceutical experience in a GMP regulated laboratory environment

• Experience/ knowledge dealing with HPLC/ICP instrumentation is desired

• Highly attentive to detail

• Self motivated, goal driven

• Experience in technical problem solving

• Good organisational skills

Total Rewards

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.

• Act as a technical and compliance liaison betwenn QC functional teams and Operations/Engineering/QA.

• Provide technical support on QC instrumentation and product testing issue within the QC unit.

• Respond actively and troubleshoot test/instrument performance issues as notified by Operations/Engineering/QA.

• Ownership of equipment system administration, calibration and maintenance to ensure availability for use.

• Technical expert in a wide range of chemical and microbiological equipment.

• Familiar with 21 CFR part 11 and how it applies to laboratory instrumentation.

• Sourcing, purchase and qualification of laboratory equipment.

• Support method validation activities, through writing and executing protocol.

• Support maintenance of laboratory servers and integration of new equipment as relevant.

• Research new technologies to improve laboratory compliance and efficiency.

• Ownership of quality systems actions (IR's,CAPA,CC) ensuring timely closure and performance trending.

• Degree in Chemistry/ Microbiology, or in a science subject or equivalent.

• Basic pharmaceutical experience in a GMP regulated laboratory environment

• Experience/ knowledge dealing with HPLC/ICP instrumentation is desired
  

• Highly attentive to detail

• Self motivated, goal driven

• Experience in technical problem solving

• Good organisational skills

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.

• Be a Visible Leader: Across the site through regular tours, genba and networking to embed processes and requirements to identify potential hazards, risk assess and reduce risks together with colleagues across the site

• Ace Collaborator and Communicator: This is a site leadership team role, and you will work closely in leading, influencing and coaching fellow leaders, management and supervisors across different departments on site, also with contractors, and other stakeholders including across the expansion program

• Safety Culture Champion: Foster a safety-oriented culture among leaders, colleagues and contractors to encourage reporting of EHS concerns and implement initiatives to continuously improve safety standards and culture

• Winning Strategies: Define EHS & ESG strategies with engaged teams delivering action plans to reduce both short-term and long-term risks and secure wins and opportunities to take EHS & ESG to the next level of success

• Lead investigations and Reporting: Lead EHS incidents, or near-misses to document findings, identify root causes, and implement corrective / preventive measures meeting GE HealthCare and local requirements

• Embed Principles: There is significant focus in ‘hard hat’ safety programs across a series of Life Saving Principles (LSP) e.g. lifting, working at heights, LOTO program, risk management, electrical safety, contractor management in drift etc.

• Build and Implement EHS & ESG Policies: Create, review, and implement policies in accordance with local regulations, GE HealthCare requirements and industry best practices ensuring these are embedded into standard work

• Train and Educate: Organise and facilitate the EHS & ESG training programs for employees, contractors, and other stakeholders to truly embed knowledge and understanding

• Good Governance: Delivering Key Performance Indicators (KPI’s) and essential metrics, maintaining related registers, protocols and other required data and documentation to deliver compliance with local and GE HealthCare requirements.

• Degree in Occupational Health & Safety, Engineering, or related field, professional accreditation in EHS with ongoing continuous Professional Development (CPD)

• Ability to work effectively and autonomously in a fast-paced environment, managing multiple tasks and stakeholder simultaneously

• Demonstrable leadership experience in a similar role with ability to work successfully in a matrix-based global organisation in situations where you have no direct line management responsibility

• Solid understanding of current legislation and regulations within EHS in Ireland

• Proven experience in health, safety and environmental management and in leading a professional team to deliver successful defined outcomes against local and global requirements

• Coaching mindset, experience in coaching and influencing others both locally and globally

• Excellent communication, leadership, and problem-solving skills

• Experience in organisation that works to lean principles and operating systems

• Experience fostering a safety-first culture in both manufacturing and construction areas

• Good experience in the use of IT systems for reporting, data management and presentation of key data and information.

• Ability to drive innovation in safety protocols using digital solutions

• Leading Security / ESG teams and / or initiatives

• Expertise in implementing AI, software, or other digital tools for EHS enhancement

• Experience in implementing and maintaining EHS / Environmental / Other standards such as ISO14001, ISO45000, ISO50001 and ISO55001.

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.

• Key member of the Quality Systems Team contributing to the overall success and direction of the Quality Operations Department.

• Act as the main point of contact for all regulatory affairs requests, providing timely and accurate information to internal and external stakeholders.

• Maintain logs of Annual Reportable Changes

• Complete Review and Approval of Annual Reports.

• Coordinate and manage completion of gap assessments of updated MDGP documents and Regulatory Guidance Documents cross functionally.

• Conduct comprehensive regulatory assessments to ensure compliance with applicable regulations and standards.

• Maintain up-to-date knowledge of regulatory requirements and industry standards.

• Prepare and submit regulatory documentation to relevant authorities such as HPRA.

• Monitor and track regulatory changes and communicate their impact to the relevant departments.

• Administer and manage activities related to the Electronic Learning Management System (ELMS), including user access, content updates, and system maintenance.

• Investigate and document Quality Assurance related deviations and escalate issues as appropriate to the Quality Systems Leader in a timely manner.

• Maintain regulatory compliance in accordance with current Good Manufacturing Practices {part of GxP} practices.

• Participate and support site audits as required

• Raise and lead change controls as required.

• Complete additional activities as required and dependent on business needs

• Suggest improvements and conduct continuous improvement activities.

• Assure site and business is properly prepared for external and internal compliance inspections by having results from their inspections be non-systemic and without warning letters. Collaborate closely with business partners to ensure site is audit ready at all times

• You have achieved at least a Professional Level 8 degree qualification in Science / Engineering discipline or equivalent knowledge or experience.

• You have previous experience in a QA Specialist Role or equivalent.

• You have previous experience with Regulatory Affairs and Regulatory Compliance.

• You are a proactive planner, and an effective communicator.

• You have some experience in working, developing strong working relationships and influencing cross-functionally.

• You have experience working with ComplianceWire, Veeva and Trackwise or equivalent.

• Excellent organisational and project management skills.

• Strong attention to detail and ability to work independently.

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.

• Act as a technical liaison between Materials Vendors / Operations / Engineering / QA/Supplier Quality

• Provide technical support on materials issues for QC / Operations / Engineering

• Respond actively and troubleshoot materials performance issues as notified by Operations / Engineering / QC

• Follow through on any specific corrective action items which have a materials performance root cause

• Proactively manage and support the introduction andvalidation/qualificationof new specifications / materials

• Propose modifications to existing specifications as part of focus on continuous improvement and cost reduction

• Analyse material performance providing specific quantitative studies to support the above

• Act as a link between the development pipeline (Tech. Development), Operations, Engineering and Materials Vendors

• Support continuous improvements projects on site

• QC materials rep. for cross functional investigations

• RelevantMaterials/Science/Engineeringqualification

• SAP and Trackwise Experience

• Strong Written and Oral Communication Skills

• Technical Writing skills.

Total Rewards

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.