Within this role you will be responsible for managing and overseeing Document Control and Archives operations. This includes oversight of the... ...the Doc Control and Archives areas
Leading organizational design and Doc Control/Vault infrastructure requirements ensuring the...
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 of...
...Summary: Provides support to the process for creating, reviewing, approving, distributing, controlling and maintaining documentation to ensure effective and efficient application of GMP.
Documentation within this process includes, but is not limited to, manufacturing and...
...directed by Team Leads and Supervisors
Ensuring all associated documentation such as manufacturing batch records & logbooks are completed,... ...tests and in-process sampling
Maintaining housekeeping in designated area and adhering to the hygiene standards of the facility...
Summary: Designs, specifies and commissions new and renovated biopharmaceutical process equipment. Provides engineering support and problem... ....
Supports validation department by preparation of design documents and assists in protocol execution.
Assists in investigations...
...users. Senior role would be the technical SME/Lead on initiatives
Responsible for system documentation, including, converting user requirement specifications to a detail design specification, writing configuration test plans and summary reports
Configuring reports (tabular...
...expertise to the Facilities Operations, Utilities & HVAC teams. Designs, specifies & commissions new and renovated biopharmaceutical utilities... ...Supporting QA Validation department by preparation of design documents and assisting in protocol execution
Assisting in...
...day might include, but is not limited to, the following:
Designing and delivering end-to-end data solutions to meet our current and... ...review requirements, specifications and technical design documents to provide timely and meaningful feedback
Producing detailed...
...electronic data systems, such as implementing new specifications, designing system templates for new/revised test methods, and designing... ...Requirement Specifications (FRSs) with current formats
Reviewing documents and ensure consistency with SOPs and current formats...
...requests across departments
Acting as a Technical SME/Lead on initiatives
Managing system documentation tasks, including converting User Requirement Specifications to Detailed Design Specifications, writing Configuration Test Plans, and creating summary reports...
...communicates items to management, business process owner and users
Responsible for IT Applications documentation, including, converting User Requirement Specifications to a Detail Design Specification, writing Configuration Test Plans and summary reports
Configuring reports (...
...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...
...cleaning, preparation and execution as well as completing associated documentation
Performing various tests and in-process sampling... ...accordance with cGMP standards
Maintaining housekeeping in designated area and adhering to the clean standards of the facility...
...Additionally, the individual processes system change controls, documents and maintains configurations to ensure that the MES remains in a... ...and establishes priorities for MES requirements gathering, system design and implementation
Responsible for maintaining MES design...
...Automation Utilities System Engineer would be accountable for the design, build and integration of the operating systems, application... ...Qualified Building Automation Systems) requirements
Ensuring documentation of maintenance activities to GxP standards in paper-based...
...high availability reducing or eliminating unplanned downtime
Designing, configuration, programming, and qualification of Rockwell... ...Creating, modification, and maintenance of automation systems and documentation, including automation specification documents and SOPs, in a...
...Senior Mechanical Design Engineer with 3+yrs experience in Mechanical design role in industry required by innovative SpaceTech company... ...project deadlines.
Lead prototype construction, testing, documentation and process development, ensuring comprehensive support documentation...
...political topics such as foreign relations and political ideology.
2. collecting data from a variety of sources, such as government documents and military cooperation news.
3. interpreting research results using statistical analysis tools.
4. predict political, social,...
Remote job
...have a high level of expertise in diverse statistical methods including multivariate regression, difference and equivalency testing, design of experiments, control charts
You demonstrate an ability for designing and implementing SPC and DOE programs
You are open and receptive...
...UL Hospitals Group is hiring a Designated Midwifery Officer (ADOM).
The Designated Midwife Officer will work as part of the University Maternity Hospital Limerick/Hospital Senior Midwifery Management Team.
The role of the HSE’s Designated Midwifery Officer (DMO) is...
Informal Enquiries:
...physical/mental/social/emotional and behavioural needs and in compliance with the Health Care Act 2007 (Care and support of residents in designated centres for persons (Children and Adults) with disabilities) regulations 2013 and the Provision of the Childcare Act 1991 and all...
...Production (Downstream Operations) a typical day may include, but are not limited to, the following.
Responsible for ensuring that all documentation (SOPs, Manufacturing Records, Batch Sheets & Logbooks) is current, accurate, reviewed and in accordance with regulatory...
...Specifications for new equipment and update old equipment SRS/ SIA. Defining standards, controls, and procedures across the lifecycle of documents.
Contact external vendors to come on site, organize induction, organize safe permit for work and supervise and approve vendor...
...input into Manufacturing records, batch sheets and procedures.
Writes, reviews, Standard Operating Procedures or other controlled documents as needed.
Provides technical input to resolve process problems both on and off the production suites
Work closely with other...
...manufacturing/utility equipment in a clean room environment
Perform daily Work Orders and PMs and efficiently coordinate the workflow and documentation of PMs and WOs
Troubleshoot the electrical equipment during off-nominal conditions; locate the source of trouble and make/...
...are not limited to:
Increasing involvement in the training of employees
Increasing responsibilities for authoring and reviewing documents/ data
Compliance representation and participation in cross functional site meetings
Technical writing assignments such as SOPs...
Within this role you will be responsible for the receipt, documentation, and movement of inventory and non-inventory items within the plant and from outside sources. This position also performs labeling and shipping functions as needed.
This is a temporary contract and a...
...to, the following:
Complying with site safety policies and striving to maintaining an accident free environment
Ensuring documentation of maintenance activities to cGMP’s standards both in paper based records and the Computerized Maintenance Management System (CMMS...
...Writing lot specific data trending reports for each lot to be released
Preparing and populating matrices (databases, spreadsheets) designed to track testing and review status of release and stability samples, lot release data, etc.
Compiling data to support QC...