|Contact Name:||Laurentina Kennedy|
The QA Specialist will be responsible for supporting the on-going development and maintenance of the Quality Management System to support WDA & ASR licenses and QP batch review & release
• 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
• 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 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.
BSc. Degree in Life Sciences is required.
3-5 years’ experience in the 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 .
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.
GDP experience an advantage but not essential
Experience working with contract manufacturers and in a virtual environment.
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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