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