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
requirements, and the appropriate Codes of Practice requirements are
- 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
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