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- ...Validation (CSV) Periodic Validation leading reviews and revalidation of computerized systems to ensure continued compliance with FDA HPRA EU Annex 11 and GxP regulations. All activities must adhere to global standards and regulatory requirements. Key Responsibilities:...SuggestedFull time
- ...Involvement in any decision to quarantine or dispose of returned, rejected, recalled or falsified products. Notify and consult with the HPRA on potential recalls or critical quality issues which may impact patient safety. Ensuring that any additional requirements imposed...SuggestedContract workHybrid workLocal areaRemote work2 days week
- ...Monitoring quality performance and advising management personnel on major quality issues. Liaison with AbbVie Global Quality Assurance, FDA, HPRA and other regulatory bodies. Regulatory review. Initiation and Completion of Quality related investigations and verification of the...SuggestedFull time
- ...specialist clinical resource, advising investigators, pharmacists, and multidisciplinary teams on trial medicines and protocols. Liaise with HPRA, sponsors, CROs, and CRAs, and prepare for and manage GCP inspections and follow-up actions. Develop, implement, and review policies...SuggestedFull timeRelocation packageImmediate startOverseas
- ...Perform risk assessments and define validation strategies for new and existing systems Support audits and regulatory inspections (HPRA, FDA, EMA) Manage change control, periodic reviews, and system lifecycle documentation Collaborate with automation, quality, IT, and...SuggestedFull time
- ...CAPA change control deviation management and risk assessments for EU qualitysystem. ~ Ensure compliance with EU GMP ICH guidelines HPRA and EMA regulatory requirements. ~ Provide leadership on quality assurance (QA) and quality management system (QMS) SOPs and quality...SuggestedFull timeContract workRemote work
- ...products ensuring adherence to regulatory requirements relevant specifications and customer needs. Communicating with regulatory agencies (HPRA) regarding Manufacturing Licences GMP inspections and any compounding product quality-related issues. Leading the audit process for...SuggestedFull timeLocal area
- ...knowledge of quality processes and systems is desirable. Demonstrated knowledge and application of industry regulations including FDA HPRA EMEA and other authorities. Keshav #LI-KV1 Required Skills: Education and Experience Third-level degree in a science or...SuggestedFull timeContract workWorldwide
- ...Proven instrumentation/troubleshooting ability. ~ Good knowledge of procedures, policies and guidelines required to comply with cGMP and HPRA/FDA guidelines. ~ Must be flexible and support the business through working shift and adhering to the standby schedule....SuggestedFull timeFlexible hoursShift workDay shift
- ...targets including OEE where applicable Provides direct interface as a subject matter expert with QA department to interaction with HPRA, FDA and applicable health authority and internal audits Qualifications So, what do you need to do this role? ~ Minimum of...SuggestedLong term contractPermanent employmentFull timeShift workNight shiftRotating shift
- ...procedures are established and consistently maintained in accordance with GDP standards, aligned with the requirements of the current EU and HPRA regulations. This is a Monday to Friday role. WHAT ARE YOU GOING TO DO? Manage the daily interfaces with supply chain,...SuggestedFull timeContract workWorking Monday to Friday
- ...understanding of regulations related to Good Distribution Practice for medicinal products for human use. Good technical knowledge of HPRA guidelines associated with Good Distribution Practice of medicinal products for human use. Proficient in using Microsoft 365....SuggestedPermanent employmentFlexible hours
- ...~ Previous experience working in a CMO is an advantage. Knowledge Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory. Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable tobiologics and/or pharmaceuticals...SuggestedFull timeContract workFixed term contractWorldwideFlexible hoursShift work
- ...knowledge of aseptic processes manipulation together with experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines. Experience in industry is desirable. Additional Information : AbbVie is an equal opportunity employer and is committed...SuggestedFull time
- ...systems and define validation requirements Represent Validation at both internal and external audits by regulatory agencies including HPRA and FDA. Generation and review of CSV project documentation (User Requirement Specifications validation protocols reports etc.) and...SuggestedFull timeLocal area
- ...Qualification Participates in any investigations that may impact the qualified state of equipment systems facilities or utilities Education & Experience: Science Graduate with minimum 5-year experience in Pharmaceutical Industry accredited by HPRA and FDA...Full timeContract workRemote work
- ...equipment is safe and functioning according to manufacturers recommendations before returning to clinical use. Act on notices received from HPRA regarding medical devices. Ensure that any medical devices considered for procurement conform to EU medical device regulation and...Permanent employmentFull timeLocal area
- ...Gemba programs and daily / weekly tiered manufacturing meetings. Provide technical expertise during regulatory inspections e.g. FDA HPRA inspections to defend systems change controls investigations and qualification packages. Support transition from project to sustaining...Full timeContract workWorldwide
- ...functional team and to manage complexity and change. • Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-...Hourly payContract workFor contractorsHybrid work
- ...Overview Complete Laboratory Solutions (CLS) is Ireland’s highest-accredited contract laboratory, licensed by both the HPRA and the FDA. An Irish-led multinational, CLS provides trusted expertise and solutions to clients across diverse sectors. CLS became part of the...Contract workWorldwide
- ...execute all drug product manufacturing operations, ensuring compliance with internal and external regulatory standards (including cGMP, HPRA/FDA). Provide leadership, direction, and motivation to a team of 8-45, ensuring effective performance, strong communication, and...Full timeShift work
- ...aligned with the principles and expectations of cGMP regulations. The successful candidate must be able to demonstrable knowledge of HPRA, EU and US GMP/GDP requirements and international guidelines governing pharmaceutical manufacturing and quality systems. This is a...Permanent employmentHybrid work
- ...ethos of Right First Time behaviors. Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines. Demonstrates leadership in continuous improvement initiatives to...Full timeShift work
- ...Qualification in a relevant science or engineering discipline Minimum 3 years’ experience in batch processing operations within an FDA/HPRA regulated pharmaceutical environment. Detailed knowledge of cGMP and regulatory requirements. At least 3 years’ experience in a...Flexible hoursShift work
- ...EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Demonstrated knowledge and testing experience in an FDA/HPRA approved laboratory. Experience in analytical technologies with particular emphasis on Bioassays (Cell based and ELISAs) and process...Full timeLocal areaFlexible hours
- .... The QA Compliance Specialist is responsible for maintaining and improving the site quality system to ensure full compliance with GMP HPRA/FDA and AbbVie quality requirements. The role includes assessing the effectiveness of the quality system and reporting outcomes to senior...Part time
- ...seek process improvements. Support quality aspects of MVI AQL and NPI process/material handovers. Maintain compliance with cGMP HPRA/FDA EHS and AbbVie standards. Qualifications : Third-level degree in science quality or engineering. Minimum 3 years experience...Full timeShift work
- ...Manufacturing. ~5+ years of experience in a medical device or pharmaceutical manufacturing setting. ~ Strong understanding of GMP/HPRA/FDA regulatory requirements and current Health and Safety Regulations legislation. ~ Familiarity with industry regulations and safety...Permanent employment
- ...manufacturing environment Good Technical writing skills Excellent communication and decision-making skills Good knowledge of GMP/HPRA/FDA regulatory requirements and current Health and Safety Regulations legislation an advantage Proven ability to work well as part...Permanent employmentFor contractorsFlexible hoursShift work
- ...capability of working and collaborating across multiple functional teams. Demonstrated capability to deliver results RFT in an FDA/HPRA Regulated production environment. Stakeholder management of multiple decision makers corporate colleagues cross-functional team by demonstrating...Full timeContract workFor contractorsWorldwide