Description
My Client pharmaceutical company based in Tipperary is seeking a Quality Assurance Manager and QP.Quality Assurance Function includes but is not limited to the following:
-Documentation Control including;
-Master Manufacturing Instructions and Packaging Specifications
-Standard Operating Procedures
-Sampling Instructions
-Test Methods
-Internal auditing according to a written schedule to monitor compliance with the requirements of GMP.
-Customer Complaints investigation and review.
-Approval of Artwork for all printed packaging.
-Procurement of required initial training and continued training of QA personnel.
-Facilitation of Internal GMP training for the facility.
-Monitor Storage Conditions for materials and products.
-Authorisation of Validation Protocols including Process Validation, Analytical Method Validation and equipment/services validation protocols.
-Authorisation of specifications and test methods.
-Organisation of Internal and External Third Party Audits.
-Co-ordination of technology transfer.
-Technical Liaison with Customers for on-going contract business.
-Vendor Certification.
-Assignment of Quality Assurance Resources.
-Inter-departmental support for Quality Issues.
-Participation in annual budget proposal.
-Participation in internal committees and work parties.
The Qualified Person Role includes but is not limited to the following:
-Act in the capacity of a Qualified Person in accordance with Directive /EC and Annex 16 of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2002.
-Provides support for all departments in Quality related issues.
-Review annual customer complaints.
-Participation in any product recall or product defects.
-Actively contribute to continuous improvement initiatives.
-Attend Quality Committee meetings.
-Conduct duties in a safe manner and report all safety issues and concerns.
-Complete all duties as per relevant SOP's
-Support investigation of deviations, ensuring all product deviations are closed prior to product release.
-Review of investigation reports.
Requirements:
-Currently approved by Irish Medicines Board as a Qualified Person, as required by Article 51 of Directive /EC
-Experience in dealing with Irish Medicines Board
-Understanding and experience of the implementation/maintenance of Pharmaceutical Quality Systems, incorporating Good Manufacturing Practice and Quality Risk Management.
-Experience in working and motivating inter-disciplinary groups.
If you are interested in this great opportunity contact me Anna Mooney or apply below with an up to date CV. Sthree UK is acting as an Employment Agency in relation to this vacancy.