...IOPS (Industrial Operations & Product Supply).
As a Materials Specialist a typical day might include, but is not limited to, the... ...experience in cGMP manufacturing operations (clinical and/or commercial External Manufacturing) or equivalent combination of education and...
...role you will be responsible for providing QA oversight and support to manufacturing... ...Standard Requirement Documents.
As a QA Specialist or Sr Specialist a typical day might include... ...the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and...
...requirements and support, follow and implement company manufacturing standards policies and procedures
A typical day as a QA Validation Specialist, may include:
Generates, executes and/or reviews master and completed cleaning validation protocols, summary reports and associated...
...manufacturing standards, policies and procedures.
As a Principal QA Validation Specialist, a typical day might include, but is not limited to, the... ...e.g. pharma, biotech, medical devices) in both internal and external regulatory audits
Scheduling, executing and reviewing/...
...to achieve a consistently high level of interaction in order to meet or exceed Regeneron’s business needs. Ensures that all critical external manufacturing requirements are driven to ensure world-class performance of product supply chains. The role of the Manager External Manufacturing...
...position will liase with the IT and broader QA organizations to ensure all aspects of IT... ...and/or defends at both internal and external (regulatory) audits and presents in a “pressure... ...approximately 25%).
Education and Experience:
Specialist: Requires BA/BS degree and 2 years of...
The Associate Manager QA is responsible for all aspects of assigned QA Team; provides leadership and support to direct reports. The Associate Manager QA for Manufacturing Operations provides QA oversight to ensure that drug substance manufacturing activities are compliant with...
...accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Oversight Specialists.
As an Associate Manager in QA Validation Oversight , a typical day might include, but is not limited to, the following:
Leading a technical...
...currently looking to fill a Quality Compliance Specialist - Change Control position on the Quality... ...Control Team. This role works within the QA Change Control Team to primarily... ...to change control owners
Meeting with External Manufacturing to discuss changes for applicable...
...Summary: This role is responsible for the operational oversite of the QA Microbiology and Lab Support Teams at the Raheen site. This person is the leader for these two organizations and must ensure personnel management (goals, feedback, development plans, priorities, etc.)...
...Summary: The Quality System Specialist participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing... ..., Facilities Maintenance, Engineering, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and...
...installation of cleanroom furniture and storage, liaising with external vendors, lead /support Manufacturing projects relating to small... ...terminations, and performance evaluations.
As a Sr equipment Specialist, a typical day may include, but are not limited to, the...
...role you will be responsible for the management and leadership of the Quality Assurance Operations function. This role will be part of the QA Operations site management team and is a key leader in the cross functional support of the manufacturing activities. This role will...
...management.
Provide insight and knowledge regarding rates, unit costs, and costing structures to enable optimal negotiations.
Uses external data sources, market information, and supplier engagement to constantly improve Regeneron’s kowledge of supply market dynamics....
...this role you will be responsible for supporting the Environmental, Health and Safety for the Limerick IOPS location.
As an EHS Specialist a typical day might include, but is not limited to, the following:
Developing, implementing and monitoring environmental, health...
...and heavily involved in technical transfer of processes.
This is a shift position, including day and night shift.
As a Process Specialist Downstream a typical day might include, but not limited to, the following:
Liaises with the process science/technology transfer...
Within this role you will be responsible for Procurement activities related to the assigned categories of spend.
As a Temp Sourcing Specialist a typical day might include, but is not limited to the following:
Responsible for end-to-end management of assigned categories,...
...Identify and maintain EHS metrics, trending and reporting of same including dashboards.
Work closely with EHS Managers and Snr EHS Specialists in selecting, adopting, implementing and overseeing appropriate programs which will enable the EHS strategy and installing them at...
The QC Compliance Specialist will be responsible for managing QC's Change Controls/CAPAs and Workflows.
In this role a typical day might include, but is not limited to, the following:
Coordination and documentation of QC quality records including but not limited to, Change...
...carry out tasks in line with the production schedule as directed by Team Leads and Supervisors.
As an Associate Biotech Production Specialist, a typical shift might include, but is not limited to, the following:
Working as part of the Manufacturing team to carry out...
...site operations. Providing compliance expertise throughout the Engineering, Automation & Facilities departments.
As a Compliance Specialist in Technical Operations a typical day might include, but is not limited to, the following:
Independently leading non-conformance...
...child disability services to adult focused disability services in the Mid-West region i.e., Clare, Limerick and North Tipperary. This specialist multidisciplinary team (MDT) for Young People with disabilities is provided by the HSE Mid-West Young Adult Disability Team (...
QA Specialist
This role participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities, Maintenance, Engineering, Materials Handling, and QA Validation in accordance with...
Limerick
9 days ago
...but is not limited to, the following:
Compiling internally and externally generated data in support of compiling CofAs and SofAs... ...lot release materials
Working with members of manufacturing, QA, RA, and R/D to provide updates/status of CofAs, SofAs, testing issues...
...batch impacting events towards closure to facilitate timely disposition of all relevant internal and external batches.
Works with key internal stakeholders (Manufacturing, QA, QC, etc) to ensure successful process execution and delivery. Supports day-to-day effective...
...function. Quality (GMP) Auditing is responsible for maintaining the external audit program and performing external audits for Regeneron IOPS,... ...with Procurement, External Manufacturing, Drug Product Quality, QA & Operations and other team members and audit clients pertaining...
...responsible for leading a team of Global Procurement Compliance Specialists that support and maintain all cGMP compliance aspects of... ...stakeholders and suppliers to drive results for Regeneron.
Uses external data sources, market information, and supplier engagement to constantly...
...against purchase orders or invoices. Maintaining paper and/or electronic records of received goods
Transferring materials physically to QA Release Area, appropriate storage location, or process area. Documenting transfers in computerized systems
Preparing and maintaining...
...piping and instrumentation diagrams and other related drawings
Developing Process Flow Diagrams for manufacturing processes
Supporting QA Validation department by preparation of design documents and assisting in protocol execution
Assisting in investigations of process...
...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 utility...