Search Results: 28 vacancies
...patient risk.
Supports the planning pipeline of quality improvement activities including initiatives to increase product quality, NCR & CAPA resolution, reduce cost, decrease in-efficiencies and improve risk management
Oversight and responsibility to ensure site maintains...
...reach consensus and ensure document approval timelines meet business needs.
Own and/or support GMP document-related Change Controls/CAPAs.
Skills Brief:
Strong knowledge of Good Documentation Practices (ALCOA), ISPE Standards,GAMP5, and Documentation Management/Life...
...in alignment with QA policies
Representing Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution
Representing the IOPS organization on behalf...
...inventory and cycle counts
Participating in the Supplier Corrective Action Request (SCAR) program
Participating in NOE’s, EOE’s, or CAPA’s as required
May be required to write SOPs
May interact with vendors, contractors, etc
Following established safety practices...
...customer/regulatory inspections
Proactively identifying and implementing lab process improvements and lean initiatives
Ensuring that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures
Training, developing and mentoring...
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...
...Conducting laboratory investigations and generating reports in response to invalid assays, Deviations, OOS/OOT
Initiating and completing CAPAs and Change Controls in accordance with site procedures
Writing new and updates current SOPs as needed
Providing training to...
...organization
Supporting the EHS incident management process on site; Managing EHS incidents to closure, including root cause analysis and CAPA management
Identifying, implementing and tracking corrective actions to prevent recurrence
Coordinating internal EHS auditing and...
...inspection of vendor and internally manufactured implants for development or investigative purposes
Metrology support for complaints, NC and CAPA investigations
Inspection and calibration of internal and vendor custom gauging
Being able to challenge Vendor and Internal...
...are not limited to, the following:
Completes investigations of technical deviations for department issues of non compliance. Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
Acts as a...
...with the creation/updating of GxP Documents
Provides Technical Writing assistance with the management of Change Controls, Deviations, CAPAs
Provides Technical Writing assistance with the completion of System Periodic Reviews.
Supports the execution of System Audit...
...devices in terms of complaint investigation and risk analysis.
Participate in engineering projects in any one of the following areas - CAPA, Design, Manufacturing, EHS or NPI.
Collaborate with other Engineering teams to ensure the effective completion of all activities...
...documentation enabling shipments
Driving compliance activities including but not limited to, changing controls, investigations and CAPA’s
Managing audit CAPA closure
Maintaining, updating and providing the status of activities via schedules and checklists
Reviewing...
€50k - €60k per annum
...deviations, non-conformances, and customer complaints, leading root cause analysis and implementing corrective and preventive actions (CAPAs) to prevent recurrence.
* Perform risk assessments and quality risk management activities to identify and mitigate potential risks to...
AVANSEL RECRUITMENT IRELAND
Limerick
more than 2 months ago
...Lead or participate in engineering projects in any one of the following Post Market Engineering areas (detailed below) as required - CAPA or Design.
Collaborate with other Engineering Teams to ensure the effective completion of all activities associated with Post Market...
...Control Programs:
Implement Microbial and Contamination Control Strategies.
Assists in complex investigations and identification of CAPA to deter recurrence.
Knowledge of KT investigation model, Root Cause Analysis and Hazard Analysis and Critical Control Point (HACCP)...
...or throughputs.
Define root cause and implement solutions to equipment and process related non-conformances utilising the NCMR and CAPA processes.
JOB REQUIREMENTS
Hold a relevant degree or equivalent qualification in production, manufacturing or mechanical engineering...
...Action/Preventative Action Process
Drive continual improvement across the organisation by leading, supporting and promoting the business CAPA (Corrective and Preventative Action) process as required
Support any IMS projects as required
Other duties as may be required...
Michaelmurphy
Rathkeale, Co. Limerick
1 day ago
...and QC teams to ensure product quality throughout the manufacturing process.
~Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality.
Regulatory Compliance:
~Stay current with industry regulations,...
...Responsible for QA review and approval of the following types of documents: Failure investigations / Corrective and preventative actions (CAPA) / Standard operating procedures (SOP’s) / GxP documents / Change control documents
Reviews various system records for assignment,...
