Overview
Title: GMP Technician
Department(s): Production and QC
Reporting To: Head of Production
Position Summary
To support the Production and QC departments with the day-to-day lab maintenance tasks.
Responsibilities
* Assist with technical operations in the GMP facility, including equipment lifecycle, goods handling, and validation activities.
* Maintain the equipment qualification tracker (WASP) to ensure GMP compliance.
* Conduct environmental monitoring in accordance with internal procedures and EudraLex Volume 4, Annexes 1 and 13.
* Ensure proper organisation and cleanliness of goods storage areas per SOPs.
* Perform temperature and humidity mapping for controlled equipment and areas as per SOPs.
* Manage GMP materials and consumables, including ordering, receiving, storing, and disposal, while monitoring inventory levels.
* Support equipment sourcing, maintenance, troubleshooting, and lifecycle management using the FEQP (WASP Asset Management Software).
* Collaborate across units to ensure timely receipt and logging of clinical deliveries.
* Assist QA with equipment and facilities-related quality records and logs.
* Support Project Managers with general project-related tasks.
* Maintain personal training records in line with training plans and policies.
* Comply with health and safety policies and COSHH regulations; may serve as Fire Marshal or First Aider if required.
* Achieve assigned goals and objectives within defined timelines.
Supervisory responsibilities
This position does not include supervisory responsibilities.
Key Relationships
* Production
* Quality Control
* Quality Assurance
* Project Managers
Travel requirements
No travel is required for this role.
Education and Experience
* GCSEs, or equivalent.
* Preferred experience in regulated environments with SOPs and GxP compliance.
* Familiarity with EudraLex Volume 4, Annexes 1 and 13 is advantageous.
* Experience in completing quality records such as change controls is preferred.
* Demonstrated ability to work effectively within a team.
Knowledge, Skills, and Abilities
* Approachable and collaborative demeanor.
* Strong attention to detail.
* Effective time management skills.
* Clear and empathetic communication abilities.
* Proactive issue escalation and resolution skills.
Physical Demands and Work Environment
While performing the duties of this job, there may be certain physical demands required for the position.
Example:
* Regularly required to lift up to 20 kg
* Requires standing for extended periods
* May be exposed to loud noise levels
Other Duties
You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.
Limitations and Disclaimer
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position. The Company is committed to making reasonable adjustments to the workplace to ensure the role is accessible to all candidates, including those with disabilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.
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