...design, implementation, commissioning and qualification of initiatives identified to improve... ...procedure development, commissioning and documentation, final handover and any other... ...and understanding of both processes and equipment (mechanical, electrical, controls etc.)...
...Within this role you will be responsible for managing and overseeing Document Control and Archives operations. This includes oversight of the following: document workflows, records issuance, paper and electronic records archives, inspection support, projects, and metrics....
...Within this role you will be responsible for the commercial Manufacturing Documentation team. Facilitate and coordinate Manufacturing records review to meet batch disposition timelines, preparation and review of Cleaning Verification Packs, PRIMR data entry and management...
...technical leadership and guidance for qualification activities and data integrity initiatives... ...to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes... ...controls, SOPs, reports and other documentation.
Coordinates with other departments...
...reviewing, approving, distributing, controlling and maintaining documentation to ensure effective and efficient application of GMP.... ...regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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...record review, Investigation support, Batch Release support, Documentation review and audits to ensure batches are manufactured in... ...recurrences.
• Management of retain samples.
• Understanding of equipment qualification, cleaning validation / analytical testing / microbial
•...
...apply for weekends, bank holidays, and qualification.
Generous holiday entitlements
Entitlement... ...inall areas and appropriately documented in line with national and locally devised... ...all times while on duty.
Report any equipment faults to person in charge and ensure all...
...quality system to include internal audits, document control and non-conforming work,... ...developing employee's skills;
• Manage equipment calibration i.e., balances, timers, thermometers... ...correctly;
•Managing the validation/qualification of test methods and test systems;
•...
EQUIPMENT QUALIFICATION SITE LEAD required by CareerWise REcruitment for our client to support their new Biologics Manufacturing Facility.
The EQUIPMENT QUALIFICATION SITE LEAD is responsible for all aspects of qualification and operations of all temperature controlled units...
...SOPs, and Regeneron Standard Requirement Documents.
As a QA Specialist or Sr Specialist... ...for troubleshooting and documentation of equipment/process/schedule disruptions
Triage... ...of employment such as identity, right to work, educational qualifications etc.
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...operating procedures (SOPs) and other documentation needed to successfully complete required... ...continuous process improvements, system/equipment implementation and/or strategy... ...employment such as identity, right to work, educational qualifications etc.
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...Procedures (SOP) and Work Instructions (WI)
Assisting in documenting proof of completion of reviews using regulatory asset... ...reviews with system owners
Assisting in periodic equipment reviews to ensure qualification status
Supporting in resolving application problems...
...technical data from manufacturing and other equipment across the network
Participating in... ...outcomes for management, supporting documentation and reports
Working effectively and... ...employment such as identity, right to work, educational qualifications etc.
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...responses for technical sections of Regulatory documents
Conducts scaled-down production... ...meetings
Maintains lab supplies and equipment
Produces and maintains accurate records... ...in scale down purification and model qualification would be an advantage.
#IRELIM #JOBSIEPR...
...Design, implement, maintain and own the analytical equipment lifecycle management process including oversight of third... ...for equipment lifecycle activities. Review GMP documents associated with equipment qualification and calibration including DQ/IQ/OQ/PQ documents for analytical...
...repairs on utility systems, manufacturing equipment and building systems in a cGMP... ...efficiently coordinate the workflow and documentation of PMs and WOs
Troubleshoot the electrical... ...for this opportunity you should have a qualification to National Craft Standard and minimum...
...Management System (PLA) and associated training documentation. The Role has responsibility for... ...archiving documents.
Systems & Equipment Proficient use of Office Systems & Equipment... ...Education:
• Third level qualification in a technical field is preferred. Exceptions...
...This position implements policies and procedures to review and approve validation/qualification documentation for equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Oversight Specialists...
...projects. You will ensure that the buildings, grounds, assets, and equipment are safe to use for all employees.
Role of this position... ...scheduled maintenance system for the entire site. Maintain all documentation related to the site and equipment.
Respond to site failures...
...and renovated biopharmaceutical process equipment. Provides engineering support and problem... ...department by preparation of design documents and assists in protocol execution.
Assists... ...employment such as identity, right to work, educational qualifications etc.
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...Ringaskiddy Cork
MUST HAVE : level 8 qualification in either Microbiology, Biochemistry,... ...troubleshooting of the manufacturing process and equipment issues and process
optimization
•... ...at all times.
• Completion of all documentation in compliance with site procedures and...
...over a period of time.
Setting up and arranging rooms and equipment to facilitate activities whilst adhering to the Manual Handling... ...tailor the activities to suit.
Record and update resident’s documentation on engagement levels during activities.
Ability to build...
...provide monthly reports.
Coordinate and document Site Health and Safety meetings.
Support... ...external bodies.
Procure site services and equipment.
Prepare site handover documentation.
Skills:
~3rd Level qualification in Engineering / Safety management
~ Experience...
...investigations to prevent reoccurrences
Reviewing Equipment Drawings, Schematics, Life Cycle Documents, and Automation programming
Reviewing SOPs, Work... ...to the commencement of employment such as identity, right to work, educational qualifications etc.
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...in GMP requirements and regulations.
Document Review/Approval
~ Responsible for approving... ...of GMP documents associated with qualification and validation including but not limited... ...PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical...
...several different activities including test method validation, equipment validation, training and developing laboratory processes and... ...relevant regulatory andquality standards
Validation and related documentation, including protocols, SOPSs, Management procedures, etc....
...and/or geotechnical engineering is beneficial). You will manage equipment, personnel and
subcontractors for the day-to-day operations... ...plant, personnel, and subcontractors.
Preparation of site documentation including RAMS, lift plans,
Manage company fleet and...
...operations (Large Scale & Sub-Suites); primarily, the qualification of Manufacturing Small Equipment, review and approval of equipment qualification packages... ..., controls, and procedures across the lifecycle of documents.
Contact external vendors to come on site, organize...
...Utilities and HVAC teams. Evaluating current mechanical plant equipment for reliability and assesses alternative options available. Maintaining... ...to demonstrate instrument suitability for change control documentation
Supervising engineering contractors
Maintaining company...
...The primary function of this role is to ensure regulatory adherence of Cook Medicals
document control process.
Reporting to: Manager, Quality Systems
~• Change Analyst within the Agile Product Lifecycle Management (PLM) system. • Processing and GMP / GDP review of...