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 results. 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 🎥🚀

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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

Salary range: £28,000 to £30,000 per annum depending on skill and experience

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 authorised 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 authorisations 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 authorisations.
• 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.