Quality Assurance Manager
This role is responsible for supporting the on-going development and maintenance of the Quality Management System.
Key Responsibilities will include:
· 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
· 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
· Support the preparation, delivery and coordination of training on GxP, QMS, SOP’s and processes.
· 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 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.
The successful candidate will have
· 3-5 years’ experience in pharmaceutical industry, preferably in areas that include quality assurance, quality systems, auditing, compliance, pharmaceutical manufacturing & distribution and/or new product introduction.
· Strong understanding of quality management systems and GMP is required.
· Experience in pharmaceutical manufacturing required in any of the following areas: laboratory, production, validation, QA
· Experience in the creation and control of SOP’s & quality systems desirable.
· GDP experience an advantage but not essential
· Experience working with contract manufacturers and in a virtual environment desirable
For more information please contact Clodagh D’Arcy on 01 9476356 or email details to Clodagh.email@example.com.