Quality Assurance Specialist

Walker Cole International Ltd; Greater London; On-site; GBP 28,000 - 36,000; Full time

Job summary

Walker Cole International Ltd. is seeking a Quality Specialist to join the Quality team in Kent. You will work closely with the Responsible Person to ensure products are stored and distributed in full compliance with EU GDP and HPRA requirements.

The role offers hands-on exposure across quality systems, complaints and deviations, supplier approvals, self-inspections, training and regulatory inspections. Experience in a GDP-regulated environment is essential, with opportunity to deputise for the

Qualifications

• At least one year of quality experience in pharma.
• Good understanding of EU GDP guidelines and HPRA requirements.
• Experience handling deviations, CAPAs, change controls, complaints or returns.
• Experience with SOPs, document control and training records.
• Strong attention to detail with excellent communication and organisational skills.
• Ability to work collaboratively across departments with a proactive approach.

Responsibilities

• Ensure compliance with Wholesale Distribution Authorisation, EU GDP guidelines and HPRA requirements.
• Handle complaints, returns, deviations, CAPAs and change controls, recorded, investigated and closed.
• Manage supplier and customer approval processes and maintain approved lists.
• Maintain SOPs, implement new procedures, track implementation and support reviews.
• Maintain training matrix and deliver GDP and SOP training to staff.
• Prepare EU batch review documents for RP approval and release.
• Support RP with recalls, mock recalls and management of quarantined, returned, rejected and falsified medicines.
• Assist regulatory and customer inspections and self-inspections.
• Collate quality KPIs and trends for QM Review meetings.
• Support updating Quality Agreements and participate in risk assessments.

Skills

Attention to detail

Communication skills

Organisational skills

Team collaboration

Regulatory understanding

Job description

Walker Cole International is supporting a well-established pharmaceutical wholesale distribution organisation in the search for a Quality Specialist to join their Quality team, based in Kent.

This is an excellent opportunity to join a GDP-regulated environment, working closely with the Responsible Person (RP) to ensure products are stored and distributed safely and in full compliance with EU GDP and HPRA requirements. The role offers broad, hands‑on exposure across quality systems, complaints and deviations, supplier approval, self‑inspections, training and regulatory inspections.

This role would suit a QA professional with at least one year’s quality experience who is looking to build their GDP expertise, with the opportunity to deputise for the RP.

You will be responsible for:

• Ensuring compliance with the Wholesale Distribution Authorisation, EU GDP Guidelines 2013/C 343/01 and HPRA requirements.
• Handling and escalating complaints, returns, deviations, CAPAs and change controls, ensuring they are recorded, investigated and closed in a timely manner.
• Managing supplier and customer approval processes and maintaining the approved lists.
• Managing SOPs, including implementing new procedures, tracking implementation and supporting annual documentation reviews.
• Maintaining the training matrix and delivering GDP and SOP training to staff.
• Preparing EU batch review documents for RP approval and release.
• Supporting the RP with product recalls, mock recalls, and the management of quarantined, returned, rejected and falsified medicines.
• Supporting preparation for, and participating in, regulatory and customer inspections and self‑inspections.
• Collating quality KPIs and trends for Quality Management Review meetings.
• Supporting the monitoring and updating of Quality Agreements, and participating in risk assessments.

The successful candidate will have:

• At least one year’s experience working in a quality department within the pharmaceutical industry.
• A good understanding of EU GDP guidelines and HPRA requirements.
• Experience handling deviations, CAPAs, change controls, complaints or returns.
• Experience with SOPs, document control and training records.
• Strong attention to detail, with excellent communication and organisational skills.
• The ability to work collaboratively across departments, with a proactive approach to continuous improvement.

Quality Specialist | Quality Assurance | QA | GDP | Good Distribution Practice | EU GDP | HPRA | Responsible Person | RP | Wholesale Distribution | WDA | Deviations | CAPA | Change Control | Supplier Approval | Self-Inspection | Recalls | Pharmaceutical