Quality Specialist 4 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.

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 experience

For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail [email protected]

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671

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