KENNY-WHELAN (a specialist division of the CPL group) are recruiting 2 MOREQA SPECIALISTS to work on contract atJANSSEN SCIENCES in Ringaskiddy Cork ContactJENNDINANviathelinkbeloworemaildirectlyto MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it QA SPECIALIST -HYBRID Role - 3 days onsite One role is for the QA Team that supports AD labs which are the Centre of Excellence for biologics, Clinical Release and Stability (Phase I-III).
Quality oversight Non-Conformance/CAPA investigations in AD.
Attend and give clear compliance input at Risk Assessments, RCPS and A3 meetings Perform the assessment and closure of change controls on time.
Support any new technologies for implementation with the BioTD AD, QC and lab services groups.
Completing Quality walkdowns of the area.
Participates as a key quality member in inspections and audits of JSCI by external parties/agencies.
The other QA Specialist will be supporting Batch records review Position General QA Description and Responsibilities This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation related to J&J projects as required by Good Manufacturing Practice (GMP).
These activities include review and approval of change controls, nonconformance investigations, and protocols.
Primary Tasks and Responsibilities Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
Supports the management of GMP compliance systems through the following activities: Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
Carries out tasks related to the administration of project and site nonconformance management systems: Reviews and/or approves nonconformance investigations and their associated documentation.
Manages entry of nonconformance records into the appropriate electronic system.
Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.
Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
Approves closure of nonconformance investigations on completion of the investigation and associated corrective actions.
Carries out tasks related to the management of project and site change control systems: Reviews and/or approves change control requests, implementation actions, and request closures.
Manages entry of change control records into the appropriate electronic system.
Tracks records from the initiation through closure processes All applications will be treated with the strictest of confidence Contact Jenn Dinan via the link below or email directly to Skills: Batch records CAPA Change controls GMP Quality Assurance Trackwise