Quality Specialist 4 Month Contract

QUALITY SPECIALIST – 4 MONTH CONTRACTOn behalf of our client, a leading healthcare company, we are currently recruiting for a Quality Specialist for a 4 month contract role. The role will report to the Quality Manager.In this role your core responsibilities will include:Responsibilities ·Support the Quality Manager and Qualified Person in maintaining compliance with Good Manufacturing Practice (GMP), for Medicinal Products, Quality Systems, local and corporate procedures, regulatory requirements, and industry standards.·Assist the Quality Manager and Qualified Person in the development of continuous improvement and compliance projects within the Quality Department. For example - Support projects as the business expands within the compounding services division.Requirements: Daily activities·Ensuring that the handling, order processing and approvals of patient scripts is completed as per the requirements of the Medical MIA. ·Reviewing and approving the Spanish patient scripts from Medical in Spain and updating the Patient ID log accordingly. ·Request the removal of stock from the quarantine block in SAP and for the verification step for Patient Specific TPN Orders prior to manufacture by Medical in Spain.·Review and co-ordinate any CAPA investigations for deviations at the Spanish site which may impact on product quality for products supplied to Medical.·Co-ordinate customer and supplier complaints - including investigations, reporting, and trending. Ensure the management of the SAP disposition of non-conforming products.Supporting Activities·Defining and periodically updating Quality Procedures in conjunction with operating staff, while ensuring compliance with GMP and GDP.·Prepare information in advance for presentation at the Quality Review Board meetings.·Assist in the completion of internal audits of GMP systems, assessing and verifying planned corrective and preventive actions and reviewing the effectiveness of the corrective and preventive actions taken.·Assist the Quality Manager in maintaining copies of the approved Specifications in the Document Management system and ensuring the relevant personnel are included in the distribution list·Recording, investigating and reporting incidents and deviations to the Quality Manager and Qualified Person.·Assisting Process Owners in assessing risks and assigning counteractive measures. ·Documenting and managing relevant change controls through to completion.·Ensure the adherence to the stability schedule.·Management of the stability data for the support of the expiry dates.·Assist in the co-ordination and documentation of product recalls and mock recalls. ·Support Pharmacovigilance and Compliance activities as required.·Responsible for issuing protocol and report numbers and maintaining associated logs. ·Compilation of reports in a timely manner, as requested. ·Assigning resources to all investigations, ensuring the acquisition of the necessary information.·Ensuring implementation, closure and effectiveness of all Corrective & Preventive Actions generated.Requirements:·The ideal candidate will have 3- 5 years’ experience in a pharmaceutical/regulated background with strong working knowledge of compounding, GMP and regulatory expectations.·Bachelor’s degree or higher; ideally in a related Science discipline·Demonstrated ability in quality systems support·Knowledge of EU quality related pharmaceutical regulations·Experience in compounding and working in a MIA environment·Knowledge of Industry Best Practices for quality and compliance related topics·Ability to process technical information·Accuracy and excellent attention to detail are key attributes along with strong organisational skills·Strong verbal and written communication skills·A proactive and collaborative work style and the ability to work with multiple priorities and deadlines·Proven decision-making capability with accountability and responsibility·SAP experienceFor a full Job Spec and to apply for this role please call Linda on 01 or e-mail Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1 #LI-LD1