Drug Product Project Coordinator - 12 Month Secondment (Maternity Cover)

Quotient Sciences; Alnwick; Presencial; GBP 30 000 - 42 000; Tempo integral

Resumo da oferta

Quotient Sciences is seeking a highly organised Drug Product Coordinator on a 12 month fixed term contract to support manufacturing activities across client projects. You will coordinate GMP documentation, maintain materials inventories and liaise with Quality Control, Microbiology and Purchasing to meet schedules.

You will work across packaging, labelling and clinical manufacturing activities, ensuring compliance with regulatory requirements and internal procedures while supporting continuous

Qualificações

• Experience in pharmaceutical/GMP manufacturing environments.
• Experience preparing, reviewing and approving manufacturing records and controlled docs.
• Strong organisational skills to manage multiple priorities and timelines.

Responsabilidades

• Coordinate activities to support manufacturing operations and delivery of clinical manufacturing projects (CMC/CTM).
• Prepare, review and approve batch manufacturing records, packing instructions and GMP docs.
• Ensure compliance with regulatory requirements and internal procedures.
• Manage GMP material inventories including ordering, receipt, storage and stock control.
• Liaise with Quality Control, Microbiology and Purchasing to ensure materials are available for schedules.
• Support investigation and approval of quality events (deviations, change controls).
• Promote health and safety and maintain safe working practices.
• Flexibly support site priorities and deputise for Head of Drug Product Operations when needed.

Conhecimentos

GMP compliance

Documentation

Project coordination

Stakeholder management

Attention to detail

Descrição da oferta de emprego

About the Role

This is a 12 month fixed term contract

We are seeking a highly organised and proactive Drug Product Coordinator to support the successful delivery of drug product manufacturing activities across a diverse range of client projects. This role is critical in ensuring manufacturing operations are coordinated efficiently, documentation is prepared and maintained to the highest GMP standards, and projects are delivered in compliance with regulatory and client requirements.

Working closely with cross-functional teams, including Manufacturing, Quality Control, Microbiology and Purchasing, you will play a key role in supporting clinical manufacturing, packaging and labelling activities while ensuring operational excellence throughout the product lifecycle.

Key Responsibilities

• Coordinate activities required to support manufacturing operations and ensure the successful delivery of clinical manufacturing (CMC and CTM) projects, along with IMP packaging and labelling activities.
• Prepare, review and approve manufacturing documentation, including Batch Manufacturing Records, packing instructions and associated GMP documentation.
• Ensure all work is documented accurately and completed in compliance with relevant regulatory requirements, internal procedures and client expectations.
• Manage and maintain GMP material inventories, including ordering, goods receipt, storage and stock control activities.
• Liaise effectively with Quality Control, Microbiology and Purchasing teams to ensure materials are available to support manufacturing schedules.
• Support the investigation, completion and approval of quality events, including deviations, change controls and other quality records.
• Promote and maintain high standards of health and safety, ensuring safe working practices are followed at all times.
• Work flexibly across the site to support business priorities and operational requirements.
• Provide support and deputise for the Head of Drug Product Operations when required.

Experience Required

• Experience working within a pharmaceutical, biotechnology or GMP-regulated manufacturing environment.
• Knowledge of GMP requirements and pharmaceutical manufacturing documentation.
• Experience preparing, reviewing and approving manufacturing records and controlled documentation.
• Strong organisational skills with the ability to manage multiple priorities and meet project timelines.
• Excellent attention to detail and a commitment to quality and compliance.
• Experience managing inventory, materials or supply chain activities within a regulated environment is advantageous.
• Strong communication and stakeholder management skills, with the ability to work effectively across multiple departments.
• A proactive and collaborative approach to problem-solving and continuous improvement.