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.

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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OTHER DUTIES

You may be asked to take on any other responsibilities or tasks that are within your skills and abilities whenever reasonably asked.

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