McKesson Quality Systems Coordinator in Munster, Ireland
PURPOSE OF JOB
The successful applicant will work closely with all Northstar departments to ensure the efficient and compliant functioning of documentation and training processes in all departments.
The role encompasses the management of NorthStar’s controlled documentation, the tracking of GMDP training and the management of documentation received from our external pharmaceutical manufacturing partners
The post holder will be process owner of the documentation and training modules on Master Control (electronic quality management system).
Responsible for the controlleddocumentation process in compliance with cGMPs, US FDA and other applicableregulations and company requirements and assist in its continuous improvement.
Ensure effective maintenance of thedocumentation management system and collaborate with department to ensureeffective resolution of document system queries or requests
Ensure Good Documentation Practices areadhered to in line with current Good Manufacturing and distribution Practices (cGMDP)
Co-ordinate the Change Control requestdocumentation from CMO sites
Participate in internal and externalcompliance audits as related to QADC activities
Maintain the GMDP training system andresponsible for ensuring all training records are maintained in compliance withcGMPs, US FDA and other applicable regulations and company requirements.
The control and management of the trainingplans for each role at NorthStar
Creation and release of courses, exams,classes, trainers and uploading of related training material
Update standard operating procedures, formsand other quality documents as appropriate, working closely with other membersof the Quality Department
Manage an effective and efficient filingand archiving system of NorthStar documents. Interact with offsite suppliersfor Document storage and retrieval
Execute testing for quality system upgrades
Liasing with Service Provider(MasterControl) on training Module Support and optimisation, including developmetrics reporting.
Issue and track annual training plan andco-ordinate quality training as required
Participate in regular team and groupmeetings
Produce reports/metrics monthly or asotherwise required
Work in accordance to NorthStar Healthcarequality standards
Provide support across the quality functionas required; be flexible in approach to work in order to meet business needs
Create and maintain presentations, policiesand procedures as required
ADDITIONAL RESPONSIBILITIES AND DUTIES
(The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned, as required, by management. When in conflict with the job description, the Staffing Request and Job Posting supersede the job description)
Third level Certificate and relevant experience
Minimum of 2 years similar experience in a multinational regulated pharmaceutical environment; preferably experience of working to quality standards in an FDA/HPRA environment.
Knowledge and Skills:
Knowledge of FDA and HPRA regulations andGMDP practices
Effective communication, presentation andreport writing skills
Excellent analytical abilities to grasp thekey points from detail and report back to the quality team
Excellent attention to detail
Proven ability to work as part of a teamand be flexible in approach to work
Excellent organisational and timemanagement skills; with the ability to prioritise effectively
Evidence of ability to work proactively andwith initiative
Excellent interpersonal skills
Previous experience on an electronic documentation system while not essential would be an advantage
Work Environment/Physical Demands:
Organization: McKesson Corporate
Title: Quality Systems Coordinator
Requisition ID: 18005782