Senior Quality Assurance Specialist

VRS Recruitment; Slough; On-site; GBP 42,000 - 60,000; Full time

Job summary

VRS Recruitment seeks a Quality Specialist to join a leading pharmaceutical organisation in Slough. The role supports QMS, deviations, CAPAs and change controls within a GxP-regulated environment.

The ideal candidate has a life science degree and QA experience in pharma/biopharma, with strong GxP knowledge, audits, inspections and supplier quality. You will collaborate across QA, Regulatory, Supply Chain and Pharmacovigilance.

Qualifications

• Excellent organisational, communication and stakeholder management skills with strong attention to detail.
• Experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
• Good knowledge of GxP requirements and Quality Management Systems.
• Experience with deviations, CAPAs and change controls.
• Experience in a GDP environment would be highly advantageous.
• Exposure to audits, inspection readiness, supplier quality and Quality Agreements would be beneficial.

Responsibilities

• Support the maintenance and execution of the Quality Management System (QMS), including deviations, CAPAs, change controls and complaints.
• Identify quality issues and risks, supporting the development and implementation of appropriate corrective actions.
• Track quality metrics, trends and KPIs and contribute to ongoing quality improvement activities.
• Support internal audits, self-inspections and regulatory inspection readiness.
• Assist with supplier and vendor qualification, Quality Agreements and ongoing quality oversight.
• Support Annual Product Quality Reviews and the maintenance of Quality training programmes and documentation.
• Ensure GxP documentation is appropriately maintained within electronic quality and document management systems.
• Collaborate with teams across Quality, Supply Chain, Regulatory and Pharmacovigilance to ensure GxP requirements are achieved.

Skills

Organisational skills

Communication

Stakeholder management

Attention to detail

Education

Degree in Chemistry, Biology, Pharmacy or Life Science

Job description

Our client is a leading pharmaceutical organisation looking for a Quality Specialist to join their Quality team in Slough. This is an excellent opportunity for an experienced Quality professional to take on a varied role supporting the effective operation and continuous improvement of Quality Management Systems within a GxP-regulated environment.

Key Responsibilities:

• Support the maintenance and execution of the Quality Management System (QMS), including deviations, CAPAs, change controls and complaints.
• Identify quality issues and risks, supporting the development and implementation of appropriate corrective actions.
• Track quality metrics, trends and KPIs and contribute to ongoing quality improvement activities.
• Support internal audits, self-inspections and regulatory inspection readiness.
• Assist with supplier and vendor qualification, Quality Agreements and ongoing quality oversight.
• Support Annual Product Quality Reviews and the maintenance of Quality training programmes and documentation.
• Ensure GxP documentation is appropriately maintained within electronic quality and document management systems.
• Collaborate with teams across Quality, Supply Chain, Regulatory and Pharmacovigilance to ensure GxP requirements are achieved.

The ideal candidate will have:

• A degree in Chemistry, Biology, Pharmacy or another relevant Life Science discipline.
• Previous Quality Assurance experience within the pharmaceutical or biopharmaceutical industry.
• Good knowledge of GxP requirements and Quality Management Systems.
• Experience with deviations, CAPAs and change controls.
• Experience within a GDP environment would be highly advantageous.
• Exposure to audits, inspection readiness, supplier quality and/or Quality Agreements would be beneficial.
• Excellent organisational, communication and stakeholder management skills with strong attention to detail.

This is a fantastic opportunity to join a leading pharmaceutical environment in a broad Quality position, gaining exposure across multiple areas of Quality Assurance and working with a range of cross-functional teams.

Keywords:

Quality Specialist, Quality Assurance, QA Specialist, Pharmaceutical Quality, Pharma QA, Quality Management System, QMS, GxP, GMP, GDP, Good Distribution Practice, CAPA, Corrective and Preventive Action, Deviations, Change Control, Quality Systems, Quality Compliance, Audit, Self-Inspection, Inspection Readiness, Regulatory Inspection, Supplier Quality, Vendor Quality, Quality Agreements, Product Quality Review, APQR, Complaints, Document Control, eQMS, Pharmaceutical, Biopharmaceutical, Life Sciences, Slough, Berkshire, VRS9525MP.