QUALITY SPECIALIST 4 MONTH CONTRACT On 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. *Bachelors 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 experience For a full Job Spec and to apply for this role please call Linda on or e-mail Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: #LI-LD1