Quality Systems Manager

Job Title: Quality Systems Manager
Contract Type: Permanent
Location: Dublin
REF: 123868
Contact Name: Laurentina Kennedy
Contact Email: laurentina@rftgroup.ie
Job Published: over 1 year ago

Job Description

Quality Systems Manager immediate start Dublin
Our global pharmaceutical client faces a busy schedule of major products launches. They wish to appoint an experienced Quality Systems Manager to support the on-going development and maintenance of the Quality Management System required for both WDA and MIA licenses. The appointee will also fulfill the role of deputy Responsible Person.

Job Spec
  • Support the development, implementation, and maintenance of the Quality Management System to ensure compliance to all relevant regulatory standards.
  • Operation and maintenance of the Document Management system to ensure control of SOPs, records and other documents.
  • Management of quality systems such as Deviation, CAPA, Change Control, Training, Complaints, Internal Audit, Vendor Management, and Risk Management to ensure compliance & escalation as appropriate.
  • Establish and maintain robust document & record retention / storage process.
  • Preparation & processing of quality documents & logs as required by the QMS.
  • Support the vendor qualification program including initial and ongoing qualification to ensure quality oversight of GxP Vendors.
  • Co-ordinate approval of suppliers, customers and associated activities such as Bona Fide checks
  • Participate in supplier & internal audits as required.
  • Support of data preparation for periodic review of the QMS and management review as appropriate.
  • Support relevant customer complaint investigations and ensure timely closure.
  • Preparation, delivery and coordination of training on GXP, QMS, SOP’s and processes.
  • Act as Deputy Responsible Person.
  • Be a key member of company audit team during regulatory or customer audits.
  • Support the development and reporting of quality metrics.
  • Partner with the global Quality department and other cross functional groups to ensure the proper application of both the corporate and Quality Management system.
  • Work in close partnership with the global Quality department and other cross functional partners to meet timelines and achieve business results.
  • Participation in the preparation of annual product reviews, annual reviews and other essential documents when required.
  • Co-ordination of documents for QP release.

Person Spec
  • Bachelor’s degree in chemistry, biology, pharmacy or a related discipline. An advanced degree desirable
  • A minimum of 5 years-experience in a quality role in a pharma company
  • Thorough understanding of quality management systems and GMP required.
  • GDP experience an advantage but not essential.
  • Experience working with contract manufacturers and in a virtual environment desirable.
  • Strong inter-personal skills including the ability to work effectively in a global team environment and to build collaborative relationships with peers and other stakeholders.
  • Highly organized with the ability to multi-task.
  • Strong time management skills
  • Ability to communicate effectively with all levels of management both verbally and in writing.
  • Good presentation skills
  • Strong experience working with electronic systems and IT platforms.
Cv to laurentina@rftgroup.ie / 01 2302400 / www.rftgroup.ie