Get new jobs by email
- ...schedules. Generate validation documentation in accordance with site procedures and regulatory guidelines including but not limited to 21 CFR Part 11 EU GMP Annex 11 and data integrity guidelines. Work closely with 3 rd parties to install computerised instrument solutions...SuggestedFull timeHybrid work3 days week
- ...technology deployment Knowledge Knowledge of GAMP software development lifecycle ANSI/ISA-S88 and S95 industry standards and 21 CFR Part 11 Strong network architecture or engineering proficiencies including TCP/IP Routing Switching Network IDS/IPS Active Directory...SuggestedFull timeLocal areaFlexible hours
- ...First Aid Response Instructor A minimum of 2 years experience Full clean drivers licence essential Qualifications Desirable CFR-A Instructor Emergency First Response Instructor Personal Attributes Strong oral and written communication skills Attention...SuggestedPermanent employmentFull time
- ...ability to work collaboratively and communicate effectively with cross-functional teams. A strong understanding of GMP GAMP5 and 21 CFR Part 11. Strong communication interpersonal skills and stakeholder engagement experience. Demonstrated leadership capability or project...SuggestedFull time
- ...manufacturing plant. A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11 21 CFR Part 11 is required. Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S...SuggestedPermanent employment
- ...innovative medical devices in accordance with the requirements of International Standards: ISO 13485, the FDA Code of Federal Regulations 21 CFR Part 820, Medical Device Directives 93/42/EEC and 2007/47/EC and the Companies Medical Quality Management System. Main Duties &...SuggestedPermanent employmentContract work
- ...a subject matter expert for software quality, ensuring deliverables meet customer expectations and regulatory requirements such as 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and EU MDR . Key Responsibilities Develop and maintain strategies to improve software...SuggestedFull timeContract work
Innovate Skillsource
Limerick7 days ago €60k - €75k per annum
...leading Design Reviews and the compilation of associated documentation. ~ Demonstrated knowledge and understanding of ISO 13485 and FDA 21 CFR Part 820 Design Control requirements. ~ Proven experience working with catheter technology, catheter design, testing, and...SuggestedPermanent employment- ...responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. The Quality Technician supports...Suggested
STERIS Canada Corporation
Westport, Co. Mayo3 days ago - ...with CAD tools and simulation software (e.g., Altium, SPICE, MATLAB). Understanding of quality systems (e.g., ISO 13485, ISO 9001, 21 CFR Part 820, EU MDR). Demonstrated ability to develop and validate test methods. Effective communicator with strong interpersonal...SuggestedPermanent employmentFull time
- ...pneumatics and industrial communication protocols Strong understanding of regulated industry documentation and validation standards (GAMP 21 CFR Part 11 etc.). Proficient in generating technical documentation for both internal and customer-facing use. Comfortable working in...SuggestedFull timeImmediate start
- ...action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c) If you need an accommodation filling out an application or applying to a job please email Required Experience: IC...SuggestedFor contractors
- ...communication skills. A strong aptitude for report writing and data analytics. In-depth knowledge of the medical device industry and of 21 CFR, (820, 11), ISO13485, specifically in the areas of Change Control and Validation. What are we looking for? A minimum of 4+ years’...SuggestedTemporary workRemote workFlexible hours
- ...relevant experience of Vendor Packaged Equipment in a GMP environment in the pharmaceutical industry. ~3 years experience of the 21 CFR Part 11 and EU Annex 11 requirements for automated systems in the pharmaceutical industry. ~3 years plus experience of plant start-ups...SuggestedLong term contractTemporary workFixed term contractImmediate start
- ...and Instrument Data Acquisition (IDA). ~ Familiarity with industry standards for software development life cycle methodologiesand21 CFR Part 11. ~ Validation and change control methodology experience with understanding of cyber security and manufacturing network principles...SuggestedLong term contractHybrid workLocal areaRemote workFlexible hours
- ...Bachelor’s degree in computer science, Engineering, or a related field. ~ Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. ~5+ Years experience in computer system validation within a regulated industry, preferably pharmaceuticals...Contract work
- ...control processes and regulatory guidelines. Adhere to data integrity principles and ensure automation systems are compliant with 21 CFR Part 11. Work closely with process engineers, IT, quality, and validation teams to ensure seamless integration and operation of...Contract workFor contractors
- ...regular status reporting to Automation Manager and key stakeholders. Ensure projects comply with GMP, data integrity requirements, 21 CFR Part 11, Annex 11 and corporate standards. If you are an experienced Project / Programme Manager with the right to work in Dublin and...Contract workDublin25 days ago
- ...Device or Pharma industry. ~2+ years in a senior or supervisory Quality role. ~ Strong knowledge of QMS and regulations (ISO 13485, 21 CFR 820, MDR). ~ Proven ability to work effectively across teams in a regulated, fast-paced environment. For a confidential...Permanent employment
- ...Drug-Device Combination Product regulatory requirements regulatory plans and high-level strategy planning including but not limited to 21 CFR 820 and MDR (EU) 2017/745. Knowledge of global Medical Device and Drug-Device Combination Product quality requirements including but...Full timeWorldwide
- ...DeviceNet Profibus ProfiNet AS-I BACnet etc. Knowledge of GAMP software development lifecycle ANSI/ISA-S88 and S95 industry standards 21 CFR Part 11 and Annex 11. Working knowledge of network architecture technologies including TCP/IP and Firewalls. Independent self-...Full timeRemote workWorldwide
- ...platform architecture system ownership and lifecycle management. Ensure that all Lab IT systems and Benchtop Analytical Equipment meet 21 CFR 11 and EU Annex 11 compliance requirements. Lead and manage a team of QC System Specialists where applicable. Provide effective...Full timeContract workWorldwideFlexible hoursShift work
- ...Quality Management System (QMS) to ensure compliance with applicable U.S. and international regulations and standards, including FDA 21 CFR Part 820 , ISO 13485 , ISO 27001 , and other applicable regulatory requirements. This position supports both internal processes and...Permanent employmentHybrid work
- ...skills. Strong report writing & data analytical capabilities. Advantageous to have knowledge of the medical device industry and of 21 CFR, (820, 11), ISO13485, specifically in the areas of Change Control and Validation. What are we looking for? Someone with a...Temporary workRemote workFlexible hours
- ...equipment is desirable; Experience with GDP & GMP (Good Documentation Practices & Good Manufacturing Practices); Experience in GAMP, 21 CFR Part 11 environments; Good understanding of Electrical & Pneumatic Panel drawings; Experience desirable but not essential with VB...For contractorsWork at officeRemote workMonday to WednesdayShift workNight shiftWeekend work
- ...available for the right candidate. Key Responsibilities: Lead and maintain the company QMS in line with ISO 13485:2016 and 21 CFR 820. Act as Quality Management Representative and support audit readiness, audit management and closure of actions. Oversee quality...Permanent employment
- ...OPC batch systems). Familiarity with GxP GAMP 5 Data Integrity concepts and regulatory expectations for computerized systems (21 CFR Part 11 Annex 11) is a strong plus. Strong documentation skills and attention to detail. Ability to learn quickly in a regulated...Full time
- ...automation engineering, with PLC/HMI/SCADA software development experience in GMP pharmaceutical environments. Strong knowledge of 21 CFR Part 11 requirements for automated systems. Experience with plant start-ups and/or new product introductions to pharmaceutical...Full time
- ...cross-functional disciplines, both within and outside of the function and organization. ~ Good working knowledge of ISA95 and ISA88, CFR (Code of Federal Regulation) Part 11, EU (European Union) Annex 11. ~ Excellent communication skills with the ability to formulate thoughts...Permanent employmentRelocation packageClondalkin, Co. Dublin9 days ago
- ...remediation and engineering development including IQ/OQ/PQ and design verification & validation ~ PMP certification ~ Knowledge of 21 CFR 820.30 - Design Controls and ISO 13485 section 7.3 - Design and Development ~ A track record of contributing to successful medical...Full timeHybrid work
