...Regeneron Industrial Operations and Product Supply (IOPS) Quality Auditing function. Quality (GMP) Auditing is responsible for maintaining... ...to be done; prioritizes and manages resources to meet audit schedules, company and departmental goals and objectives, and quality deliverables...
Summary: The Quality Compliance Coordinator supports data trending, process monitoring, and... ...with the delivery of training, such as scheduling training sessions, maintaining rosters,... ...CAPA assignment.
Assists as needed in audits and inspections.
Contributes to ensure...
...DIVE into a CAREER with AURA!
We are looking for a Swim Coordinator on a Full Time basis to join our team at Aura Grove Island
Why join the Aura Family?
We are the best in our industry! We don't just talk about our values; we live them every single day....
...tasks
Proficient in wide array of departmental activities
Coordinates multiple pre-fixes and/or processes across multiple areas and sites... ...as integral resource or team member for regulatory and internal audit and inspection logisticsCOMPLIANCE SUPPORT
Leverages subject...
...Temporary Works Coordinator - Limerick (Hospital Project)
Benefits
~ Great Salary on offer
~26+ days annual leave
~ Pension
~ Multiple other benefits
A Tier 1 contractor has a vacancy for a Temporary Works Coordinator to be based on a hospital project in Limerick...
...duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary... ...SME with respect to data integrity, audit and manages upgrades. Implements data... ...within project documentation
Leads and coordinates equipment qualification projects from initiation...
...production to approved protocols, regulation, and schedule.
Supervises a team responsible for the... ...in accordance with cGMP standards.
Coordinates and ensures quality system instances meet... ...actions and change controls.
Ensures audit readiness and coordinates where required....
...in validated state to support production schedule
Responsible for communication of site... ...-day activities and projects, as well as coordinating work with appropriate internal departments... ...are complied with as evidenced by internal audits and inspections from Government Agencies...
...aligns with site policies and processes
Coordinating the needs of functional groups across the... ...Ensuring GxP compliance
Responding to audit inquiries
Collaborating with... ...Manufacturing and Technical Training to develop and schedule training sessions that best serve the...
...supply quality, delivery and efficiency
Coordinating logistic documentation enabling shipments... ..., investigations and CAPA’s
Managing audit CAPA closure
Maintaining, updating and providing the status of activities via schedules and checklists
Reviewing manufacturing...
..., medical devices) in both internal and external regulatory audits
Scheduling, executing and reviewing/approving qualification activities... ...approving change controls, SOPs, reports and other documentation
Coordinating with other departments or outside contractors/vendors to...
...cause analysis and CAPA management
Identifying, implementing and tracking corrective actions to prevent recurrence
Coordinating internal EHS auditing and inspection and actively following up on necessary corrective actions to ensure audit readiness
Identifying and...
...manufacturing process according to approved protocols, regulation, and schedule.
Can be involved in Supporting investigations into process... ...input.
Represents manufacturing during regulatory and client audits.
Implements continuous improvement initiatives.
This role...
...including root cause analysis and CAPA management.
Identify, implement and track corrective actions to prevent recurrence.
Coordinate internal EHS auditing and inspection and actively follow up on necessary corrective actions to ensure audit readiness.
Responsible for the...
...reagents inventory
Participating in the overtime and weekend schedule as required
Performing bioburden and endotoxin testing of... ...commercially prepared microbiological culture media
Assisting in coordinating equipment maintenance and calibration
Performing all duties...
...contract and/or business partner manufacturing sites, including scheduling batches, supply of materials, direct shipment of bulk and... ...evaluating cost/benefit scenarios, making sound recommendations and coordinating internal and external resources to address issues
Ensures...
...resource assigned to functional area to meet goals and timings; coordinates prioritisation of activities with area management.... ...regulatory observations are adequately addresses and completed on schedule.
Authorises significant deviations to established, approved...
...also provide support during regulatory inspections and internal audits and work to ensure that all identified content is organized,... ...inspections and audits, ensuring timely and accurate audit response
Coordinating responses to regulatory or partner audits
To be considered...
...typical day might include, but is not limited to, the following:
Coordinating, organizing and assigning the daily/short term activities of... .../programs
May support the site through regulatory audits by providing technical expertise
Assigning training to team...
...the commercial Manufacturing Documentation team. Facilitate and coordinate Manufacturing records review to meet batch disposition... ...Performing people management duties including time sheet submissions, scheduling of vacations, personnel development, disciplinary actions, hiring...
...implementation.
Participation in internal, regulatory and customer audits.
May train personnel on quality system processes.
May... ...to lead many diverse tasks simultaneously.
Effectively coordinates and runs work responsibilities under general mentorship.
Proficiency...
...typical day might include, but is not limited to, the following:
Coordinating across business departments and stakeholders, gathering and... ...Leading IT Applications systems security access and periodic audit trail reviews
Supporting day to day activities for IT Applications...
...typical day might include, but is not limited to, the following:
Coordinating across business departments and stakeholders, gathering and... ...or may lead IT Applications systems security access and periodic audit trail reviews
Other duties as assigned
This role may be for...
...utilities, facilities, HVAC, & building systems
Planning and scheduling maintenance repairs/modifications of facility and process... ...issues
Performing daily Work Orders and PMs and efficiently coordinating the workflow and documentation of PMs and WOs
Performing or...
...technical quality review team by developing appropriate plans & schedules, resource loading, developing validation best practices,... ...Validation Oversight Specialists to meet goals and timings
Coordinating prioritization of activities with area management
Participating...
...program to ensure program adherence in accordance with approved schedules.
Analyzes the results of testing and determines the... ...approves change controls, SOPs, reports and other documentation
Coordinates with other departments or outside contractors/vendors to complete...
...mechanical technicians to ensure work is carried out to a high standard and within project time frame and budget.
• Coordinate and allocate work schedules for the mechanical team, ensuring that work is completed in a timely and efficient manner.
• Ensure that all work carried...
€ 24 - 39 per hour
AgencyNurse –Flexible Shift Schedule
~Beautiful Healthcare Facilities based inLimerick
~Develop Professionally in a Supportive Team
~Well-Established Facilities with a Stellar Reputation
Take your career to the next level at these healthcare facilities located in the...
...support requirements of the manufacturing operations team. Provide direction and troubleshooting guidance. Maintain safety compliance and audit readiness and ensures objectives are delivered to a high standard and on time. This is a extended days shift position. As a Manager...
...of the Batch Disposition / Order management process, effectively identifying potential risks to the timeline and cross-functionally coordinates mitigation plans to maintain original timeline or reduce delay and impact.
Reports risks and follows proper escalation path as...