Quality Assurance Specialist

2 months ago

Windsor, United Kingdom Parkside Recruitment Full time

Reference:
- 89777- Sector:
- Administration, Medical Secretary- Salary:
- £40,000 to £45,000 Per Annum- Benefits:
- bonus- Town/City:
- Windsor- Contract Type:
- Permanent- Date Posted:
- 13/06/2023 15:34:00An amazing opportunity for a Quality Assurance Specialist to work for a dynamic and vibrant organisation within the pharmaceutical industry, my client have a diverse group of motivated individuals who have a passion for delivering innovative products that offer better health to patients worldwide. As well as passion, the people have many other qualities in common, they are creative, curious, entrepreneurial, open-minded and able to think outside of the box

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.

1 day per week in my clients amzing offices

**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

Parkside Recruitment Ltd is acting as an Emp

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