Snr Quality Assurance
4 weeks ago
PE Global are recruiting for aSenior QA Specialistfor our biopharmaceutical client based in Dun Laoghaire, Dublin.This is an initial 12-month contract role.Hybrid working, 3 days a week onsite.We are seeking an experienced Senior Quality Assurance Professional to provide quality direction and oversight for activities related to the installation of new syringeand inspection lines at our facility in Dun Laoghaire.This role requires a strong understanding of Quality requirements associated with aseptic manufacturing, as well as an excellent understanding of C & Q / Validation requirements.The desired candidateshould have a proven track record in QA leadership, and be comfortable working as part of a cross functional team.Job ResponsibilitiesQuality Oversight of new equipment qualification:Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System ValidationAct as the Quality point of contact and decision-maker C & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.Validation and Documentation:Quality review and approval of validation documentation, including:Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAES).Validation Plans, Protocols (IQ, OQ, PQ), and associated reports.Ensure robust and compliant validation documentation to support site activities.Risk Management and Compliance:Conduct risk assessments and develop mitigation strategies for potential challenges in equipment introduction.Provide input and quality oversight for change control development and implementation.Ensure timely and robust implementation of change controls and CAPA records.Documentation and SOPs:Write, review, and approve Standard Operating Procedures (SOPs) in alignment with company policies.Regulatory and Safety Compliance:Ensure all activities align with company safety standards, SOPs, and regulatory expectations.Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.Educations & ExperienceUniversity degree in a Science or Engineering-related discipline.Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.Proven expertise in new equipment introduction, technical transfer, PPQ execution, and lifecycle management.Strong understanding of validation principles and regulatory requirements for C & Q / Validation (FDA, EMA guidelines).Experience with change control, non-conformance resolution, and CAPA implementation.Excellent organizational, communication, and collaboration skills.Ability to work independently with minimal supervision and operate effectively across functional boundaries.Critical thinking and problem-solving abilities.Additional Skills:Familiarity with Quality by Design (QbD).Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus.Team-oriented mindset with the ability to thrive in a collaborative decision-making culture.Interested candidates should submit an updated CV.Please click the link below to apply, or alternatively send an up-to-date CV***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****
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Snr EHS Specialist
6 days ago
Dublin, Ireland Arcadis DPS Full timeSnr EHS Specialist About Arcadis Arcadis is the worlds leading company in sustainable design, engineering, and consultancy for natural and built assets. With over 36,000 professionals across 70+ countries, we are united in our mission to improve quality of life and solve the worlds most complex challenges. Be part of something meaningful join us! Snr EHS...
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Quality Assurance Manager
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Quality Assurance Technician Lusk
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Dublin, Ireland Healthcare Businesswomen’s Association Full timeJob Description Summary Job Title: Snr. Developer (R), Advanced Quantitative Sciences, Tech & Scientific Computing #LI-Hybrid Primary Location: Dublin, Ireland Other Locations: London, United Kingdom Relocation Support: This role is based in Dublin, Ireland. Novartis is unable to offer relocation support: please only apply if accessible. Join us in shaping...
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Quality Assurance Analyst, Senior
4 weeks ago
Dublin, Ireland Enterprise Registry Solutions Ltd. Full time**Company Name:**Enterprise Registry Solutions Limited**Job Close Date:** 18th of NovemberWe are**ERS,** a leading international registry provider operating out of Dublin, Ireland.We design, build, and operate registry solutions that power public and private sector operations and drive efficient business decisions around the world.Our people are what drives...
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Senior Quality Assurance Specialist
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Dublin, Ireland Scientificjobs Full timeSenior Quality Assurance Specialist (Shift)RK4701Contract 12 monthsDublin We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties: Ensure adherence to...
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Quality Assurance Specialist
6 days ago
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