Senior Change Management Specialist
|Job Title:||Senior Change Management Specialist|
|Job Published:||over 1 year ago|
Our client, a medical device company in Cork, are currently looking to recruit a Senior Change Management Specialist for their site.
The Change Management Specialist will primarily be responsible for the oversight & assessment of changes to the quality management system. The CMS will oversee and ensure that changes to quality management system documents & processes are compliant, effective and pose no risk to the quality of the product/processes.
? Lead & execute the change control board, including coordinating and directing (multi-site) ECRB Boards.
? Assess and challenge document changes for applicability to responsibility matrices & compliance to processes.
? Supports and mentors the Change owner.
? Change analyst & approver, review of changes regarding documentation, plausibility, correct classification, compliance with the specified standards and regulations, particularly the rules applicable CC procedures.
? Challenges the rationale, justification and resulting status of change requests.
? Be Process SME and will assist in audit representation
? Co-ordinate the change control process plant-wide and across multiple sites ensuring timeliness in compliance with procedure.
? Develops the training of change control process procedures and forms.
? Monitoring and presentation of specific KPIs, data analysis, support for the collection of quality data and preparation of reports, management forums.
? Creates collaborative interfaces between divisions & GQO sites, and departments such as Design, Quality and Operations at product, process, system, or supplier related changes.
? Lead implementation of internal and external policies
? Development and implementation of training courses, Creation of role profiles for training of users.
? Drive development and implementation of quality data and reports to improvement and optimization of business processes / results
? Identify and report any quality or Compliance concerns and initiate immediate corrective actions if necessary
? Ensuring compliance with the quality regulations ( QSR ) , the cGMP requirements through participation in internal audits , support the reduction of essential critical Audit objections
? Monitoring and participation in the optimization of interface processes (internal and external) e.g.: Manuf-transfer, etc. Phase Out
? Partner and attend discussions on global processes, corporate forums, collaborate arenas to improve change control Processes systems.
? Can relay IS discussions proficiently.
? Thinks about CMS from an IT perspective, proficient in understanding SRS / URS.
? Bachelor degree/ Masters of Science, Engineering or equivalent/ related subject required and a Minimum of 4 years? experience in areas of Quality Management Systems
? Minimum of 7 years in Quality/Regulatory Affairs environment
? Experience working in a regulated environment required.
? Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
? Thorough knowledge and understanding of US and International Medical Device Regulations.
? Strong knowledge of Quality Systems (e.g. CAPA, Audits, Management review, Quality Planning).
Percent Travel Required Up to 20%
For further information on this Senior Change Management Specialist role in Cork please contact Cliona O?Malley on 091730022 / email@example.com
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