PE Global are currently recruiting a QC Supervisor for one of our Pharma clients in Limerick. Permanent position, offering an excellent salary package. The successful candidate will be responsible for the laboratory quality control testing of in-process, stability, and final drug products, as well as team management and, will have technical responsibility for all bio-analytical aspects of QC testing.ResponsibilitiesCoordinates with members of Manufacturing, Stability, and Business Ops to provide analytical support.Manages QC Analysts distributes workload and monitors progress.Manages product testing to ensure efficient and compliant operations.Reviews test reports.Ensures QC Analysts receive proper training.Attends meetings to keep informed of manufacturing priorities.Ensures that safety standards are maintained.Ensures compliance with applicable cGMP regulations and SOPs.Investigates atypical and OOS test results as necessary.Manage assay transfer internally from R&D to the QC laboratory or from PAS to the QC Laboratory.Manage assay transfer externally from QC laboratory to contract labs, includes audits if needed.Manages QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections, and its readiness.Track and coordinate major analytical investigationTrack and monitor the timeline of analytical validation projects.Monitor the team performance for Compliance events, track, assist, and organize continuous improvement events.Interact with Regulatory Agencies as needed to ensure cGMP compliance.Special projects as assigned.Performs personnel management functions including timesheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations

PE Global is currently recruiting for a Quality Systems Specialist for a client site in Dublin –The role of the Quality Control (QC) System Specialist will provide quality support and expertise to the QC laboratory and ensure the supply of quality pharmaceutical products in meeting the Manufacturing Division Priorities of Compliance, Supply, Strategy and Profit Plan. The team working style is one of collaboration, coaching, and facilitating to provide Quality oversight and expertise to the laboratory team to support a High Performing Organisation.Our Quality Control group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers, and suppliers we create an interdependent global manufacturing network committed to delivering compliant, reliable supply to customers and patients on time, every time, across the globe.The QC System Specialist operates as part of a self-directed team in carrying out day to day function and assigning priorities.The QC System Specialist participates in departmental initiatives on improved compliance and quality systems.PRINCIPAL ACCOUNTABILITIES:The QC System Specialist assures compliance with all safety and environmental requirements.The QC System Specialist delivers a robust Quality Management System for Dublin Systems such as Waters© Empower and Labware© Global Laboratory Information Management System (GLIMS) to support a flexible, collaborative, multi-skilled teamwork environment.The QC System Specialist completes System activities such as:Raw Material / Excipient updates based on Quality System Changes requests.Drug Substance / Drug Product updates based on Quality System Changes requests.In Process / Cleaning Validation key changes updates to meet the campaign start-up deadline.

Summary: Oversees the laboratory quality control testing of in-process samples, sampling of utilities and manages the environmental monitoring program.Essential Duties and Responsibilities include, but are not limited to, the following:• Manage a team of laboratory analysts within the QC microbiology department involved inthe analysis of intermediates (in the process) and bulk drug substance in a cGMP regulatoryenvironment. Distribute workload and monitor progress.• Manage the environmental monitoring program, including surface, settling, and viableand non-viable particulate air monitoring of aseptic operations and controlled areas• Manages product testing to ensure efficient and compliant operations.• Ensure that all work carried out is in compliance with the required regulatory standards,conforms to company policies and standard operating procedures (SOPs).• Review and approve method protocols, reports, and SOPs.• Assist in the preparation for internal/customer/regulatory inspections.• Ensure a safe working environment within the laboratory.• Proactively identify and implement lab process improvements, lean initiatives.• Oversee or conduct laboratory investigations and generates reports in response toinvalid assays, Deviations, OOS/OOT.• Ensure that CAPAs and Change Controls are initiated and completed on time and inaccordance with site procedures.• Present analytical data reports clearly and concisely to senior management, including QCperformance metrics and trends.• Ability to train, develop and mentor direct reports and effectively manage theperformance of individuals.• May be required to work shift

Excellent career opportunities with one of Ireland's leading Bio-Pharma companies.If you have a degree in Microbiology or a related discipline, and a minimum of 12 months of experience working in a Microbiology Laboratory in a GMP environment we would love to hear from you.We will also consider candidates that have previous food industry experience and chemistry-related backgrounds.This is a great opportunity to join our award-winning team partnering with one of the world's top pharmaceutical companies.The ideal candidate will be good team players, organized, accurate, have strong documentation skills, and be passionate about quality and customer service. They will have a flexible approach to changeable working patterns and be available for shift work.Successful applicants will have the opportunity to work as part of a dynamic, progressive company. Excellent terms and conditions offered.Please note that these roles will involve shift work 12/7 pattern

PE Global is currently recruiting for QA Specialist for a client site in CarlowQA Specialist:- Responsible for ensuring that the process for the manufacture of the drug product is incompliance with cGMP and the associated regulatory requirements.- Ensure that quality issues are identified, addressed, and resolved before activitiescommences.- Responsible for supporting deviation and atypical closeout and initiating/following up oncorrective and preventative actions.- Provide detailed knowledge of quality systems in place and ensure that the root cause isidentified and corrective actions as appropriate are completed.- Support the development and implementation of improved quality reporting measures.- Aid the effective implementation of the Quality Management System, and facilitate thecontinuous improvement of same ensuring the Quality Management Systems areaccurate and complete; review on a continuous basis.- Initiate and maintain Quality related metrics, ensuring effective communication andfollow-up of the same.- Actively participate in Plant/Quality committees and works with other site functionalgroups.- Partner with colleagues cross-functionally to provide support and advice on day todaybasis and on a project basis including communications, training, project work,audit/inspection duties, investigations, customer queries, etc.; thereby ensuringthe department is audit/inspection ready.Education:Primary degree in scientific disciplineRelevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing GMP setting.Experience of Sterile manufacture preferred.Knowledge of EU/US quality-related pharmaceutical regulations

dcdcdc

PE Global are currently recruiting for a QC Lims Administrator for our client site in West Dublin:Duties:*The QC gLIMS Administrator will be responsible for coordinating, facilitating, and undertaking activities pertaining to the Thermo Fisher Sample Manager LIMS system (gLIMS). The QC gLIMS Administrator will build, develop, and maintain LIMS templates and be involved in troubleshooting as required. This role will support The Quality Control team.Skills:*The building, testing, verifying, transferring, reviewing, and activation of all data required for Master Data Load in gLIMS.*Identify area end-user requirements and enhancements to assist with Master Data Load in gLIMS.*Ensure the system master data is updated in a timely manner as required by the area.*Assist in validation (IQ, OQ, PQ) as required*Author/review of validation protocols and reports to ensure compliance with current regulatory expectations.*Investigation of deviations and raising of change controls as required.Show lessRequirements:3 years in a QA/QC/Validation/IT function with strong knowledge of CSV/GAMP, 21 CFR Part 11, Project Life Cycle and cGMP Regulations governing GxP dataMinimum of degree qualification in relevant science and/or IT disciplineGood working knowledge of laboratory testing processes and automation using various instrument software packages.Direct experience maintaining master data in a cGMP environment is required.