This role is responsible for supporting the on-going development and maintenance of the Quality Management System for to support both WDA and MIA licenses.
This position reports to the Executive Director of Quality and will fulfill the role of Deputy Responsible Person for the WDA license.
- 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 the 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.
Education & Experience Requirements
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
A 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 interpersonal 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
For further information on this QA Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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