Quality Assurance Coordinator

About Us

At
Chapter 2
, we're not just scaling businesses—we're reshaping the future of talent acquisition with
passion, loyalty, and an unwavering commitment to result
s. By blending people, processes, and cutting-edge technology, we've redefined the traditional RPO model, delivering faster, smarter, and more cost-effective solutions that exceed expectations.

As a global powerhouse, our team spans the UK, South Africa, the US, and Germany, with India as the next frontier in our ambitious expansion. Having grown 1300% in just two years, we are unstoppable fuelling our momentum with honesty, collaboration, and a shared vision.

We are relentless in our pursuit of excellence, embedding world-class talent, pioneering technology, and compelling employer branding into organizations across industries. Our approach isn't just about recruitment—it's about building long-term success for our clients.

We are loyal to our clients, to our vision, and most importantly, to each other—because we know that true success is built together.

Chapter 2 – A scalable talent solution.

For more information, please watch the Chapter 2 Evolution

Quality Assurance Coordinator

Sector:
HealthTech / Access to Treatment

Type of role:
Permanent

Location:
East London

Office expectation:
The successful candidate is expected to be in the office 4 days a week, with working from home on a Thursday, please note this is essential

Please note for the first 2 weeks of onboarding, the successful candidate will need to be on site every day.

Working days and hours:
Monday to Friday, the client is happy for candidates to work 8.30am to 5pm or 9.30am to 6pm

Benefits:

• 27 days annual leave
• Birthday leave
• Private Medical Insurance
• Gym discounts
• Cycle to work scheme
• Fantastic modern office environment with amenities
• Strong leadership and support team

Role Overview

The Quality Assurance Coordinator is involved in the following:

• In Good Distribution Practice (GDP) of pharmaceutical products and is responsible for monitoring GDP activities
• Overseeing record keeping of Wholesale Distribution Authorization (Human Use) / WDA (H) activities
• Preparing appropriate reports for management.

Breakdown of duties of the role:

• Record keeping and documentation control - 25%
• Incident, deviation and recall management - 25%
• Audits, self-inspections and CAPA oversight - 20%
• Regulatory compliance and license management - 15%
• Reporting and meetings - 10%
• Admin - 5%

Key Responsibilities:

To ensure compliance with Good Distribution Practice (GDP) principles and the effective management of the company's Wholesale Distribution Authorization (Human Use) license, the Quality Assurance Coordinator will be responsible for:

• Ensuring products are imported only from approved countries with MHRA and Home Office approvals, and that Controlled Drugs (CDs) are supplied exclusively to authorized customers.
• Maintaining accurate records of acquisitions and sales in the Controlled Drugs (CD) Register and ensuring timely submission of the Home Office Annual Return.
• Implementing and monitoring initial and ongoing supplier qualification checks.
• Ceasing the import or supply of products if instructed by the MHRA or when a UK-licensed equivalent becomes available.
• Immediately notifying the Responsible Person (RP) of any issues affecting the safety or quality of unlicensed medicinal products.
• Verifying customers and prescribers and carrying out ongoing due diligence periodically.
• Recording sales order data in real time, verifying customer orders, and ensuring compliance with monthly supply regulations.
• Updating the Controlled Drugs Register and maintaining documentation related to picking, packing, and dispatch, retained for the required period.
• Reporting incidents promptly to the Responsible Person and assisting with investigations, complaints , and deviations.
• Supporting the Responsible Person with product recalls and return investigations.
• Ensuring goods are purchased only from bona fide suppliers to protect the supply chain against falsified medicines.
• Maintaining accurate stock records in the Controlled Drugs Register, including amendments for non-conforming, damaged, or expired stock, and obtaining destruction authorizations as needed.
• Conducting monthly checks to verify that stock records at the Admin Site match those at the Contract Storage Site, assisting with any discrepancy investigations.
• Identifying staff training needs, informing the Responsible Person, and coordinating training for new staff.
• Maintaining and implementing the self-inspection schedule, ensuring Corrective and Preventive Actions (CAPAs) are completed within agreed timelines.
• Reporting Quality Management System (QMS) performance to the Responsible Person and planning weekly Team Quality Meetings.
• Managing the control and proper disposal of pharmaceutical waste, including stock record amendments and destruction authorizations.
• Keeping the Responsible Person informed throughout all risk assessments and assisting in timely risk closure.
• Ensuring that all necessary export documentation is available and complies with legal and administrative restrictions, including sanctions and embargos.
• Maintaining accurate, real-time, and up-to-date records for all transactions in compliance with GDP standards.
• Ensuring the accuracy and retention of Controlled Drugs Registers, Pick & Pack Orders, and all compliance documentation.
• Keeping real-time, legible, and backed-up system records.
• Ensuring that validation activities involving Excel spreadsheets meet the requirements as outlined in internal work instructions.

Essential Person Specification:

• Maintain exceptional attention to detail, working accurately with high volumes of information and at pace.
• Uphold core values and high standards of care.
• Exhibit flexible and adaptable working styles in a dynamic healthcare environment.
• Advocate for a culture of feedback and continuous improvement.
• Possess excellent communication and interpersonal skills.
• Embrace technology, being IT literate and able to navigate multiple systems.