Quality Assurance Compliance Specialist

Parkside Recruitment. ,
Slough, Berkshire
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Overview

We are currently recruiting for a Quality assurance compliance specialist within Product quality . The responsibilities are to Contribute to the maintenance of the European quality system in order to ensure that quality assurance and regulatory compliance activities are fully adequate, and that the company fully complies with all relevant legislation and industry recommended practice . Experience of quality , documentation , inspections and distribution as well as knowledge of improvement management , audits and pharmaceutical legislation . Experience of leading and implementing process development and improvement activities who has a flexible approach, able to adapt to changing circumstances and new opportunities; encourages, leads, facilitates and drives change . Develop and maintain the quality management system to assure compliance with GMP and GDP Plan, implement and perform internal quality audits Monitor and report on product non-conformities Manage and maintain systems for change control, deviation and CAPA Manage and maintain a system for product complaint handling ensuring timely completion and reporting. If necessary, assist in any product recall Collect, collate and compile data for periodic product quality reviews, including preparation of reports Assist in conducting external/supplier audits as required Review batch release documentation and coordinate correction of any errors Assist in maintaining the system for document control, so that the current local and regional SOP systems are managed both in hard copy and electronically Maintain documentation archiving systems Prepare and maintain GMP documentation such as standard operating procedures Conduct training sessions on QA systems as required Contribute to Global Quality goals, projects and initiatives Processing of Product Returns forms including usage decision Quality Control Provide support in the planning and scheduling of laboratory testing Initiate follow-up action on out of specification materials Liaise with contractors and the laboratory on sample quantities and sampling frequency Ensure stability testing is performed in accordance with the requirements of the marketing authorisations High attention to detail Very good written and spoken English Excellent time management and organisational skills Ability to pro-actively identify issues and seek resolution Experience in management of GMP/GDP Quality Management Systems Experience in management of product quality complaints Experience of Electronic Document Management Systems Additional relevant QA experience Excellent written and verbal communication skills Ability to learn quickly and adapt quickly to changing requirements Ability to work to tight deadlines Good problem solving skills Several years' Pharmaceutical industry experience in QA (GMP and GDP) Ideally qualified to minimum of Batchelor's degree Parkside Recruitment Ltd is acting as an Employment Agency in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer. This job was originally posted as www.totaljobs.com/job/89903056

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