Search Results: 59 vacancies
...testing in preparation for QA Specialist or Qualified Person disposition activities
* Compiling, Review and approval of minor NC and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and...
Dublin
7 days ago
£51.6k - £59.4k per annum
...characterization, tech transfer and validation.
* Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer.
* Interfaces with manufacturing as well as all support functions to provide robust and coordinated support...
Dublin
9 days ago
€50k per annum
...Team player who can work effectively and proactively on cross-functional teams.
Experience/understanding of complaint handling or CAPA processes are desirable
Must have excellent communication skills both oral and written.
Auditing experience to the requirements of...
Dublin
8 days ago
...requirements for example CSV and SDLC.
Support the review & approval of key quality deliverables including SDLC Change control Deviations CAPAs. Etc.
Attend periodic review meetings cutover migration hyper care support any enhancements planning design and/or implementation...
€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
Bray, Co. Wicklow
9 days ago
...regulatory and industry standards.
Perform routine entries in the local calibration maintenance software.
Participate in deviations CAPA s and change control s related to the maintenance of instruments in alignment with team priorities.
Provide support to maintain a...
...of six sigma LEAN and root cause analysis tools used for identifying and correcting deviations.
Day to day management of Deviation CAPA and Change Control metrics
Support the oversight of the quarterly deviation trending process (by cross functional area owners) on a...
...assessments and changes ensuring appropriate actions are implemented timely.
Provide QA review and approval of Change Controls Deviations/CAPAs SOPS and related documentation for compliance to GMP and site requirements at the facility.
Provide QA oversight to GMP readiness...
...characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to...
...reliability and efficiency of manufacturing processes in addition to daytoday support related to unplanned event troubleshooting investigations CAPA identification and implementation.
Requirements
Primary responsibilities:
Perform as a knowledgeable subject matter expert...
...of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
Day to day management of Deviation CAPA and Change Control metrics
Support the oversight of the quarterly deviation trending process (by cross functional area owners) on a...
...Determination
Ensure effective integration of feedback from validation, field service, post-market surveillance, manufacturing indications, CAPAs, HRAs, etc.
Demonstrate familiarity with ISO 14971 and IEC 62304 standards for medical device risk management and software...
...Implementation of new procedures and policies
o Training: Assisting with GDP and procedural based training
o Management of Deviation and CAPA's within the Quality Management System
o Management of Change Control's within the Quality Management System
o Management of Risk...
...pharmaceutical company with offices in Dublin, we are collaborating with them on a new vacancy for a Quality System Specialist (Deviations and CAPAs)
The primary purpose of this position is the management of the Quality System functions in the organisation in relation to...
...Risk Management effectively integrates feedback from validation, field service, post-market surveillance, manufacturing indications, CAPAs, HRAs, etc. Familiarity with ISO 14971, Risk management for medical devices and IEC 62304 Medical Device Software.
Understand and support...
...Conduct Global Patient Safety-related non-compliance investigations for minor events including trending and support investigation and CAPA implementation of any significant quality events based on established documented procedures associated with benefit-risk deliverables....
...business partners to support compliant and timely execution of quality management systems (QMS) records such as deviations, investigations, CAPAs, change controls and laboratory investigations.
Integrates knowledge and experience as skilled specialist with knowledge of...
...execution/testing.
Work directly with method transfer lead.
Support Laboratory Investigation Record (OOS/OOT) and general Deviation/CAPA completion.
QC SOP and Test Method drafting/update/review.
General laboratory systems support and troubleshooting.
Become...
Takeda
Dublin
21 hours ago
...Including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversight
This may be the right role for you if you have experience:
Leading Quality Risk Management activities on clinical...
...and Utility PQ studies Cleaning Validation SIP process validation Support sustaining activities such as Change Management Deviations CAPAs Equipment Requalification and Periodic review Site Maintenance & Calibration Program.
Provides support to internal audits and regulatory...
