Callum Roberts

A dual-role professional supervising Quality Control and supporting Quality Assurance functions within a regulated pharmaceutical environment.

Key Responsibilities:

• Managed a team of QC Associates, allocated workload and set priorities for efficient workflow.
• First point of contact for quality related issues for operations personnel.
• Author, manage, review and approve various documents pertaining to the Quality Management System - Non-Conformance Reports, Corrective Action Preventative Action (CAPA) Reports, Change Controls, Risk Assessments, Standard Operating Procedures (SOPs), Validation Documents, Material Specification, Work instructions and Training Documents.
• Maintain and monitor site compliance to SOPs and training.
• Perform goods-in inspection of GMP-regulated products (drug products, devices, packaging and labels.
• Conduct packaging room line clearance, start-up, in-process and end-of-job inspections, ensuring batch records align with special instructions and conform with SOPs.
• Perform quality approval on shipments: Clinical Site Shipments, inter-office Shipments and Just-in-time shipments.
• Participate in product recall activities: documentation, traceability and client communication.
• Assist the Qualified Person (QP) in preparing QP Declarations/Certificates, including supply chain diagrams and regulatory reviews.
• Deliver regular training workshops to promote quality culture in regards to GxP.
• Oversee products approaching their expiration date: Track, quarantine and expiry extend products approaching shelf-life.
• Lead or participate in internal, client, supplier and regulatory audits (e.g., MHRA).
• Maintain the European GMP/GDP document archiving systems (manual and electronic).
• Approve and review product packaging configurations, label releases, and manufacturer-supplier documentation.
• Collect and collate licenses of approved suppliers shipping product to and receiving product from site.
• Liaise regularly with clients during project meetings and issue resolutions.

Key Achievements:

• Successfully supported MHRA and client audits with zero critical findings, reflecting robust QA systems.
• Designed and delivered internal training programmes, improving audit preparedness and compliance rates.
• Streamlined processes surrounding product approval processes for new clients, reducing onboarding time and documentation gaps, as well as, final product approval processes.

Key Responsibilities:

• Performed detailed inspections of materials and processes to ensure compliance with quality standards.
• Verified documentation accuracy and maintained traceability through systemic data entry and record keeping.
• Assisted in audit activities, SOP development, and employee training on quality procedures.
• Supporting product release and monitoring of expiration dates to maintain operation integrity.
• Collaborated with stakeholders to resolve quality concerns ans maintain high service standards.

Key Responsibilities:

• Manage day-to-day batch record activities in secondary packaging rooms.
• Oversee manual label application, assembly and inspection procedures.
• Train new starters in Xerimis SOP and GxP principles.
• Ensure cleaning procedures are followed between batch records.

Key Responsibilities:

• Designing and printing of clinical labels, using EasyLabel software.
• Perform manual label application, assembly and inspection procedures.
• Involved in the Continuous Improvement Forum.

Key Responsibilities:

• Responsible for opening, closing and maintenance of the store.
• Till work, upselling and customer management.
• Processing deliveries and online orders.

Key Responsibilities:

• Maintaining the venues, cleaning and stock levels.
• Independently manning bars.
• Selling alcohol in compliance with legislation.

Key Responsibilities:

• Selling insurance and credit to customers in compliance with legal requirements.
• Counting, processing and managing stock.
• Processing and packing home delivery and online orders.
• Acting as the first point of contact for customer queries.