Overview
(GMP) Production Scientist Jobs in Surrey, England, United Kingdom at MedPharm
Title: (GMP) Production Scientist
Company: MedPharm
Location: Surrey, England, United Kingdom
General Information:Title: Production ScientistDate: Site: Guildford
Department: Production
Reporting To: Head of Production
Position Summary:
To assist in the running of the GMP clean rooms, storage areas and GMP campaigns to ensure manufacture and packaging of clinical trial material is in line with agreed schedules, customer requests and is compliant with GMP regulations.
Essential Functions:
To lead manufacture, packaging and labelling campaigns for investigational medicinal products for use in clinical trials
Working knowledge of the training requirements set out in Eudralex 2003/94/EC and the application of these regulations to MedPharm’s training policies and procedures
To provide technical input for manufacturing projects and clinical trial supplies. Support the Head of Production in performing root cause analysis and OOS investigations
Prepare GMP documentation. E.g., batch manufacturing records, quality documents and validation protocols
To assist in the running of clean rooms and Production storage areas to ensure compliance with all GxP regulations
To assist with the maintenance, calibration, verification and validation of laboratory equipment in line with GxP regulations
To assist in the maintenance and cleaning of equipment and utensils in line with MedPharm procedures
To report any deviations from BMRs and SOPs to management
To assist Process Development in Technical and Tox batch manufacturing
To ensure all documentation, computer data and records are stored appropriately
To ensure the production areas are kept to the required standards of tidiness and cleanliness
Ensure that all activity is undertaken in line with MedPharm H&S policy and COSHH regulations and to ensure the safety of others in any procedures or tasks performed
To adhere to SOPs appropriate to the role and assist in the preparation of new SOPs and updates
To assist in preparation for audits and inspections
Maintenance of personal training file
Supervisory responsibilities:
None
Key Relationships:
Head of Production
Process Development Team
QA
QC
Project Managers
Suppliers and contractors
Education and Experience:
Bachelor’s degree
Experience within a GMP role
Experience with EudraLex volume 4, and Annex 13
Experience in completion of quality records such as change controls and deviations
Knowledge, Skills, and Abilities
Approachable
Attention to detail
Good time management
Good communication
Ability to effectively escalate any given issue and take advice to help reach a resolution
Quality ambassador: promotion of a quality ethos in support of efficient and compliant manufacturing activities
Physical Demands and Work Environment
While performing the duties of this job, there may be certain physical demands required for the position.
Examples:
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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