Parkside Recruitment
Quality Assurance Specialist
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An amazing opportunity for a Quality Assurance Specialist to work for a dynamic and vibrant organisation within the pharmaceutical industry
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 where they can learn, develop 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
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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
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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
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