Quality Assurance Specialist

An amazing opportunity for a Quality Assurance Specialist to work for a dynamic and vibrant organisation within the pharmaceutical industry# We require a candidate to be available to start within 2 weeks Main areas , CAPA , GDP , Trackwise The role is offered on a 12 Month fixed term contract with Hybrid working 1 day per week in the office We are currently recruiting for a Quality assurance Officer who has 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 . Solid experience of GDP , SOPS, GXP , CAPA with excellent communication skills and the ability to work cross functionally The ideal person will have around 2 years experience and is looking for a role and team were they can learn , development and take responsibility within a high performing team

Job functions

-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 -Implement and maintain a QMS in compliance with requirements for medical devices Key responsibilities

• Develops, implements and manages the Quality Assurance policy of the affiliate by ensuring a robust Quality Management System (QMS) is in place
• Embeds quality, risk management, and continuous improvement principles
• Ensures effective investigations and root cause analyses of issues are completed and
• appropriate Corrective and Preventive Actions are identified and implemented
• Facilitates the conduct of Risk Assessments and the development of Risk Mitigation Plans,
• and monitors mitigation actions
• Establish, implements and manages a documentation system, able to fulfil legal and
• corporate requirements
• Develops and implements a Change Control system management linked to the Corporate
• QA Change Control management system
• Organises internal audits for the affiliate, in order to evaluate the compliance to local
• regulatory requirements, and Corporate requirements
• Informs Corporate QA about inspections, and provides the adequate corrective /
• preventive actions to Inspectorates in agreement with Corporate QA
• Involved in writing of all Quality Agreements signed by the affiliate, especially where there
• is subcontracting regulated activities
• Regulatory compliance ‐ write, review, develop, validate and maintain local regulatory
• SOPs in line with local regulatory legislation, guidelines, issues, practices and Corporate
• procedures
• Responsible for the management of release and updating of Summary of Product
• Characteristics (SmPC) and Patient Information Leaflets (PIL)
• Good Distribution Practise (GDP) compliance – the Affiliate's expect in matters related
• to the distribution of product
• Liaise with Responsible Person for activities requiring specialised input/decisions
• Responsible for product recall
• Corporate image and Compliance
• Ensure that prevailing legislation, GCP, Ethical Committee, and SOP and local requirements, and the appropriate Codes of Practice requirements are fulfilled
• Contribute proactively to a credible image for the affiliate in the local Health
• Care and Medical community
• Performs data entry into Global Intake Tool / Argus or its equivalent for processing
• safety reports
• Local processing of spontaneous reports received from health care professionals,
• non‐healthcare professionals, authorities, literature and conference presentations Qualifications and Requirements Degree in pharmacy, life science or a recognised healthcare professional degree / qualification
• Good knowledge of Quality Systems Management, GDP, GMP, GCP, Regulatory and
• Pharmacovigilance legislation where appropriate
• Practical experience leading and implementing process development and improvement
• activities that embed quality and drive continuous improvement
• Experience in process mapping and writing process documents.
• Flexible approach, readily adapting to changing circumstances and new opportunities;
• encourages, leads, facilitates and drives change where appropriate
• Challenges and questions ways of working to seek improved processes
• Excellent attention to detail