Our client is an Irish incorporated generic pharmaceutical company. They focus on the development and manufacturing of pharmaceutical products. They use 3rd Party manufacturers all over the world, all holding valid EU GMP and/or FDA approval. They then license out their products to clients globally. The team behind this organisation have significant experience within the European generic industry and today these people are focused on bringing this know-how to Ireland. This is a young company vibrant company that offers excellent opportunities to their employees.
Specific Responsibilities of QA Officer
-Management of Documentation Control
-SOP document generation and review
-Non-conformance review and follow-up of Corrective Actions
-Preparation of the Internal Audits Schedule and ensure completion of the internal audits
-Preparation of External Audit Schedule and ensure all actions are closed following completion of the audit.
-External auditing of the component suppliers and contractors when required (with the QP)
-Co-ordination and final approval of customer complaint/recall handling (in conjunction with Quality Manager and QP)
-Ensure Quality Manager/QP are appraised on all Quality related issues.
-Deviation review and approval (with Quality Manager and primary QP )
-Management of Change control review and monitored to ensure closure in a timely manner.
-Maintenance and update of the Product Specification folders on the shared server (in conjunction with the MAH)
-Following up and obtaining Product Quality Review Reports from Contractors and preparation of the same.
-Liaise with the Quality Manager/Qualified Person, as necessary, on technical issues including deviations, CAPA. Where relevant the expertise of the regulatory colleagues who are the MAH shall be obtained.
-Liaise with the MAH in relation to Marketing Authorisation variation updates/PIMA Licence updates as required and to ensure that the product has been repacked as per the agreed specifications.
-Assist in the preparation all Quality Quarterly reports
-Vendor evaluation through questionnaire as required
-Maintenance of retention of reference samples and batch documentation stores
-Liaise with customers for component queries in relation to Quality as required
-Generation of QA Despatch documents (including Batch Release Certificate)
-Maintenance of the Master List of Products to be released ( in conjunction with the Quality Manager and QP)
-Generation and maintenance of Technical Agreements with Suppliers and Customers as required (with Quality Manager and primary QP)
-Approve contract packaging documentation such as Packaging Instructions/Batch Production Records as required and ensure all necessary checks have been completed with the BPR for QP Release.
-Ensure compliance to the conditions of the Manufacturing Licence and compliance to GMP in all activities which affect Product Quality.
-Degree in related area.
-Experience of working with CMO’s and Technical Agreements
-Minimum experience of 10 years
-Excellent negotiation and interpersonal skills, ability to develop and maintain business relations.
-Strong planning, analytical and problem solving skills
-Languages: main language English, other languages are optional and beneficial
Contact Brian Christensen on 01 6854747 or submit your CV to email@example.com for immediate consideration
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747