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).

KEY RESPONSIBILITIES

  • 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)

REQUIREMENTS

Education/Training:

Third level Certificate and relevant experience

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

PC/Equipment:

MS Office

Previous experience on an electronic documentation system while not essential would be an advantage

Work Environment/Physical Demands:

Office based

Job: Medical

Organization: McKesson Corporate

Title: Quality Systems Coordinator

Location: Ireland-Munster-Cork

Requisition ID: 18005782