...Analytical Technologies, IPC lifecycle, Data Analytics, Manufacturing Support, Process Validation and Process Solutions. As a Temp Data Review Associate you will establish, organize and maintain effective process data co-ordination and data evaluation services. A typical... 

Regeneron

County Limerick
11 days ago
 ...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... 

Regeneron

County Limerick
2 days ago
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... 

Regeneron

County Limerick
21 days ago
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.... 

Regeneron

County Limerick
25 days ago
 ...and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. As a QA Specialist or Sr Specialist a typical day might include...  ...Performing area walkthroughs Providing oversight and review of documentation for non-routine work such as Area in PAAS, Incursions... 

Regeneron

County Limerick
3 days ago
 ...resources Building effective relationships with other departments and functions within the organization Compiling, reviewing and approving documentation Driving continuous improvement initiatives/programs May support the site through regulatory audits by providing... 

Regeneron

County Limerick
5 days ago
 ...and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. Essential Duties and Responsibilities include, but are not limited...  ...following: Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to... 

Regeneron

County Limerick
3 days ago
 ...but is not limited to, the following: Authoring and peer reviewing of failure investigations/deviations relating to QC operations...  ...employees Increasing responsibilities for authoring and reviewing documents/ data Compliance representation and participation in cross... 

Regeneron

County Limerick
10 days ago
 ...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 requirements. Leads, motivates, and manages the... 

Regeneron

County Limerick
11 days ago
 ...Key person for technical 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... 

Regeneron

County Limerick
11 days ago
 ...troubleshooting activities associated with the manufacturing process Supporting technology transfer activities as needed. Reviewing Manufacturing documentation associated with the transferred process To be considered for this opportunity you should have a BS/BA in Life... 

Regeneron

County Limerick
7 days ago
 ...Ensures, in collaboration with the team, the timely routing and review of all technical transfer activities, validation plans, master...  ...records (MRs), standard operating procedures (SOPs) and other documentation needed to successfully complete required clinical and commercial... 

Regeneron

County Limerick
12 days ago
 ...process equipment and manufacturing Assisting in the design review, site acceptance and installation of equipment Preparing piping...  ...Supporting QA Validation department by preparation of design documents and assisting in protocol execution Assisting in investigations... 

Regeneron

County Limerick
25 days ago
 ...role Performing equipment cleaning, preparation and execution as well as completing associated documentation Performing various tests and in-process sampling Reviewing, editing and revising completed batch records, Logbooks, and SOPs in accordance with cGMP standards... 

Regeneron

County Limerick
13 days ago
 ...cross functional teams to resolve issues, complete investigations and maintain compliance. Responsible for QA review and approval of the following types of documents: - Failure investigations - Corrective and preventative actions (CAPA) - Standard operating... 

Regeneron

County Limerick
17 days ago
 ...solutions or recommendations for changes and/or improvements. Reviews, edits, and approves deviation notifications, deviation...  ..., edits, and approves change controls, SOPs, reports and other documentation. Coordinates with other departments or outside contractors/vendors... 

Regeneron

County Limerick
25 days ago
 ...include, but is not limited to, the following: Coordination and documentation of QC quality records including but not limited to, Change...  ...Control/CAPA events and align team on approach forward Reviewing, editing, and revising controlled documents ( logbooks, SOPs,... 

Regeneron

County Limerick
26 days ago
 ...business process owner and users Responsible for IT Applications documentation, including, converting User Requirement Specifications to a...  ...Applications systems security access and periodic audit trail reviews Other duties as assigned This role may be for you if you... 

Regeneron

County Limerick
2 days ago
 ...ambiguity into actional steps. Ensure appropriate communications between IOPS and global RA in a timely manner • Review the content and format of regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements, scientific... 

Regeneron

County Limerick
9 days ago
 ...operations of off-site manufacturing. This role is responsible for reviewing process data to ensure operational consistency after the...  ...equipment readiness, analytical process transfer, manufacturing document creation, etc. Reviewing and approving cGMP batch documentation... 

Regeneron

County Limerick
20 days ago
 ...identifying and recommending corrective actions Assisting in the design review, site acceptance and installation of equipment Supporting QA Validation department by preparation of design documents and assisting in protocol execution Assisting in investigations of... 

Regeneron

County Limerick
25 days ago
 ...troubleshooting activities associated with the manufacturing process Supports technology transfer activities as needed Reviews Manufacturing documentation associated with the transferred process To be considered for this opportunity you should have a BS/BA in Life... 

Regeneron

County Limerick
11 days ago
 ...quality program. In this role a typical day might include, but is not limited to, the following : Gathering data and documenting test results Reviewing test results to ensure compliance with standards; reporting any quality anomalies Complying with all pertinent... 

Regeneron

County Limerick
27 days ago
 ...strategy Thinking critically, troubleshooting proactively and solving complex problems Experiencing review requirements, specifications and technical design documents to provide timely and meaningful feedback Producing detailed documentation to a high standard This... 

Regeneron

County Limerick
21 days ago
 ...global projects aimed at harmonizing laboratory data system Reviewing updates to regulatory guidelines for electronic data systems to...  ...Requirement Specifications (FRSs) with current formats Reviewing documents and ensure consistency with SOPs and current formats... 

Regeneron

County Limerick
19 days ago
 ...Acting as a Technical SME/Lead on initiatives Managing system documentation tasks, including converting User Requirement Specifications to...  ...Applications systems security access and periodic audit trail reviews Supporting day to day activities for IT Applications Providing... 

Regeneron

County Limerick
12 days ago
 ...Technical Writing assistance with the creation/updating of GxP Documents Providing Technical Writing assistance with the management of...  ...Technical Writing assistance with the completion of System Periodic Reviews. Supporting the execution of System Audit Trail Reviews... 

Regeneron

County Limerick
26 days ago
 ...process materials, or stability samples in support of the company’s quality program. Capturing data and documenting test results. Completing test records and reviewing data. Calibrating or verifying calibration of instruments/devices prior to use. Reviewing test... 

Regeneron

County Limerick
27 days ago
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... 

Regeneron

County Limerick
27 days ago
 ...Additionally, the individual processes system change controls, documents and maintains configurations to ensure that the MES remains in a...  ...Functionality Specifications, and Configuration Specifications Reviews company documentation including SOPs, Batch Sheets and/or... 

Regeneron

County Limerick
29 days ago