Get AI-powered advice on this job and more exclusive features.
This range is provided by Parkside Recruitment. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
An amazing opportunity for a Quality Assurance Specialist to work for a dynamic and vibrant organisation within the pharmaceutical industry.
Hybrid working 1 day per week in the office.
We are currently recruiting for a Quality Assurance Officer who has experience in quality, documentation, inspections, and distribution, as well as knowledge of improvement management, audits, and pharmaceutical legislation. Experience in leading and implementing process development and improvement activities is essential. The ideal candidate will have a flexible approach, be able to adapt to changing circumstances and new opportunities, and encourage, lead, facilitate, and drive change.
Solid experience of GDP, SOPs, GXP, and CAPA with excellent communication skills and the ability to work cross-functionally is required.
The ideal person will have around 2 years of 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.
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.
* Establishes, implements, and manages a documentation system to fulfil legal and corporate requirements.
* Develops and implements a Change Control system linked to the Corporate QA Change Control management system.
* Organises internal audits for the affiliate to evaluate compliance with local regulatory requirements and Corporate requirements.
* Informs Corporate QA about inspections and provides adequate corrective/preventive actions to Inspectorates in agreement with Corporate QA.
* Involved in writing all Quality Agreements signed by the affiliate, especially where there is subcontracting regulated activities.
* Responsible for the management of release and updating of Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL).
* Liaises with Responsible Person for activities requiring specialised input/decisions.
* Responsible for product recall.
* Ensures compliance with prevailing legislation, GCP, Ethical Committee, and local requirements, and appropriate Codes of Practice.
* Contributes 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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Health Care Provider, Production, and Quality Assurance
Industries
Pharmaceutical Manufacturing and Hospitals and Health Care
#J-18808-Ljbffr