in accordance to cGLP or cGDP practices, including records in site electronic systems e.g. M-ERP / VQMS / LIMS etc. On time... CI Processes, support of site CI / HAPs projects. Excellent communication/interpersonal skills with a strong affiliation...
of applicable regulatory requirements (GxP & EHS) Quality systems management (e.g., Non-Conformance, Change Control, CAPA... support to the Maintenance team and Senior Maintenance Technicians on shift. Technical management of corrective and preventive...
requirements. Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations... process for the manufacture of drug product at our Carlow site is in compliance with cGMP and the associated regulatory...
maintenance and operation of facility systems, including HVAC, utilities, cleaning, waste management, and laboratory systems... opportunities. Initiate and support capital project proposals for facility upgrades and improvements. Collaborate with cross...
data models, reporting systems, data automation systems, dashboards and performance metrics support that support key... Operations Manager will work closely with the technology reference data, data science, infrastructure, support, cyber, and risk...
and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security... Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures...
Financial Controller to lead and manage all financial operations. This includes corporate accounting, regulatory and financial.... Develop, implement, and enhance internal control systems and accounting policies. Collaborate with external auditors...
of Clean Utility Systems, ensuring all necessary documentation is executed. Prepare and manage all C&Q test documents..., including C&Q Plans, FAT, SAT, IV, FT, and Summary Reports. Provide technical support during investigations and system design...
stringent customer and regulatory requirements. Key Responsibilities: Supervise the daily operations of the quality control team... to ensure compliance with internal and external quality standards. Develop, implement, and maintain quality assurance systems...
and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security... Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures...
. Ensuring all the systems are in compliance with all Regulatory requirements including Quality (cGDP/GMP’s), EHS, Global... Engineering, design & construction directives, requirements & procedures, as well as all Local Regulatory requirements. Support...
by providing technical support for process improvements, equipment installation, and facility modifications. Collaborate with cross...-functional teams, including operations, quality, maintenance, and EHS, to implement project solutions efficiently. · Regulatory...
scale, support, inclusive culture, and technology to become the best version of you, we are counting on your unique voice... within a global and EMEIA network across EY and provides C-Suites with insight and services to support the derivation of business...
. We are seeking a QC Instrumentation Engineer to provide equipment lifecycle management support to the Lilly Limerick QC Laboratories.... Main support functions include specifying and purchasing equipment; authoring equipment qualification packages, managing...
will support aligning pricing strategies and incorporate regulatory requirements, data sharing, and analysis that will drive.... – Clinical Supply, Tax, Pricing, and Legal) to support business and regulatory needs. Strong organizational skills with the...
. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing... processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the...
with regard to ongoing development of current processes and systems and future development needs. Develops detailed Project Plans... to support major new product/process introductions. Provides Technical Leadership in the selection, design, optimisation...
on managing and improving the calibration and instrumentation systems at a cutting-edge biopharmaceutical manufacturing facility.... Your expertise will ensure that equipment operates safely and efficiently, meeting all regulatory standards. Please note...
– Associated facilities, supply chain office areas. All operational areas to implement EHS site standards in support of safety... and Transport companies are operating in line with regulatory and licence expectations and relevant quality agreements. · Ensure...
of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations. To learn...: Support the coordination of artwork updates as required ensuring no missed implementation dates (including the generation...