Quality Specialist 6 Month Contract

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.

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.
• 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 the verification step for Patient Specific TPN Orders prior to manufacture by Medical in Spain.
• Review and coordinate any CAPA investigations for deviations at the Spanish site which may impact on product quality for products supplied to Medical.
• Coordinate customer and supplier complaints - including investigations, reporting, and trending. Ensure the management of the SAP disposition of non-conforming products.
• Define and periodically update 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.
• Record, investigate and report incidents and deviations to the Quality Manager and Qualified Person.
• Assist Process Owners in assessing risks and assigning counteractive measures.
• Document and manage relevant change controls through to completion.
• Ensure adherence to the stability schedule.
• Manage the stability data to support expiry dates.
• Assist in the coordination and documentation of product recalls and mock recalls.
• Support Pharmacovigilance and Compliance activities as required.
• Be responsible for issuing protocol and report numbers and maintaining associated logs.
• Compile reports in a timely manner, as requested.
• Assign resources to all investigations, ensuring the acquisition of necessary information.
• Ensure 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 experience.