Our Client is an independently owned and operated company that works exclusively with clinical trial materials. The UK site provides secondary packaging, labelling and distribution of clinical trial supplies for sponsor company organisations. Their facility near Reading serves as the packaging and distribution hub for clinical trial materials to Europe and the rest of world.
Due to continued growth, they are now seeking an Operations Manager
to join their dynamic team. This position is a full-time permanent role and will be based near Reading, Berkshire.Job Purpose
Key Areas of Responsibility
- This position is responsible for the management of the Operation group and ensuring overall GXP compliance with all procedures affiliated with receiving, storing, label production, packaging, distributing, returns processing, disposition of clinical supplies and project coordination.
- The role will also have responsibility for capturing and capacity planning / scheduling the future packaging / labelling / distribution needs of the UK facility and the associated staffing requirements.
Qualifications and Experience
- Collaborates with leadership team in the UK and US facilities
- Oversees all GXP activities related to receiving, storing, label production, packaging, distribution, returns processing, disposition of clinical supplies and assigned project management activities
- Assists and ensures that all Operations personnel follow and perform all policies and SOPs in accordance with GXP and as specified
- Assists with the creation and revision of SOPs
- Capture record and communicate the overall packaging demand V's Client requirements using long and short view planning methodologies
- Identify resourcing requirements and staff training / development requirements within the Operations group
- Oversees the contracted activities related to the Preventative Plan Maintenance (PPM) Schedule, and the suppliers which carry out additional services for the UK facility
- Assures that qualified individuals are GXP trained to perform their respective job relative to handling and/or processing clinical supplies.
- Coordinates with Quality Assurance to maintain GXP and SOP compliance within the Operations group
- Participate in planning meetings, initial study discussions with Client regarding packaging designs and project tracking meetings as required
- Oversees the generation of, and review of, labelling and packaging documentation, shipping documentation, and the processing of all shipments of clinical supplies
- Oversee the randomisation approval process, including mapping of randomization files to the label print system following client approval
- Oversee the batch record creation process, including the creation of packaging samples
- Oversee the label production, label inspection and label accountability processes
- Oversee the material specification creation process
- Oversee the acquisition of materials for use in clinical studies, including cartons, labels, temperature data loggers, shipping systems etc.
- Participates in Client and Competent Authority audits for the UK facility as required
- Coordinates Investigations within the operations team to resolve non-compliant events in coordination with Quality Assurance department (CAPA)
- Ensures that close contact is maintained with clients, couriers, custom brokers, and domestic and/or foreign shipping regulation organisations
- Coordinates with other departments to meet project timelines and identify any associated risks and constraints.
- Creates a culture of safe working by observing and promoting observance of all relevant H&S SOP's and practices
- BSc or equivalent in a scientific subject is desirable but not essential
- Solid experience in clinical trials supply is desirable
- Strong knowledge of the pharmaceutical industry and GXP
- Strong managerial experience
- Excellent interpersonal and communication skills
- Excellent Numeracy and Literacy
- Proficient in MS office tools
- Attention to detail
In return our client is offering a competitive package of around £55,000 per annum basic plus benefits for the successful Candidate. (Salary is negotiable dependent on experience. More may be available for an exceptional candidate).
Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.