Quality Assurance Specialist

Parkside Recruitment; Windsor; Hybrid; GBP 30,000 - 40,000; Full time

Job summary

Parkside Recruitment seeks a Quality Assurance Specialist for a dynamic pharmaceutical organisation. The role is a 12-month fixed-term contract with hybrid working one day per week in the Windsor office.

You will contribute to GDP/GMP compliance, document control, and CAPA processes within a cross-functional team. The ideal candidate has about 2 years of QA experience, strong communication skills, and a proactive attitude to drive change and continuous improvement.

Qualifications

• Degree in pharmacy, life science or healthcare is required.
• Good knowledge of Quality Systems (GDP, GMP, GCP) and regulatory guidelines.
• Experience leading process development and improvement activities.
• Experience mapping processes and writing process documents.
• Flexible, proactive, capable of driving change and cross-functional collaboration.

Responsibilities

• Develop and maintain a Quality Management System to ensure GMP/GDP compliance.
• Plan and perform internal quality audits and supplier audits as required.
• Monitor product non-conformities and implement CAPA actions.
• Manage change control, deviation handling, and CAPA workflows.
• Oversee release of product documentation including SmPC/PIL with regulatory compliance.
• Support regulatory and quality activities to ensure timely reporting and recalls if necessary.
• Drive continuous improvement and risk mitigation within a high-performing team.

Skills

Quality Assurance

GDP

GMP

GCP

CAPA

Audits

Documentation

Process Improvement

Education

Degree in pharmacy, life science or healthcare

Tools

Global Intake Tool / Argus

Job description

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 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/decisionsResponsible 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

• 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