JOB DESCRIPTION:

The Manufacturing Operations student has a very important role to play in GC’s commitment to quality and efficient manufacturing operations. Specific and varying duties will be given to the student in relation to their assignment but some key tasks and responsibilities are outlined below. They must be capable of working as part of a very flexible team in a demanding, regulated environment. They are required to proactively contribute to the delivery of manufacturing targets within quality, safety and environmental requirements and on schedule. This role is based in the production facility and not in a laboratory environment.

RESPONSIBILITIES:

• Carry out and monitor manufacturing operations using the relevant manual or electronic Batch Manufacturing Instruction and Record (BMR) and Standard Operating Procedures (SOPs) or other Protocol.

• Actively participate in problem identification, problem solving and change initiatives in cooperation with other teams and services. Continuous improvement with a cross functional focus is a core activity.

Environmental, Health & Safety

• Actively foster, in cooperation with other TILGC staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.

• Adhere fully to all safety policies, procedures and regulations.

Quality Systems and GMP

• Assist in the preparation of reports in relation to deviations and/or investigations, as required.

• Generate documentation associated with their activities as required by cGMP, Health and Safety and Environmental regulations or management systems.

Training

• Ensure that staff are well trained to safely and effectively carry out their roles. Develop training for relevant personnel with a particular focus on direct operational and technical support personnel.

• Lead/actively participate in all training and assessment activities in the manufacturing department.

• Preparation and delivery of training materials.

• Ensure timely completion of all SOP training and assessment tasks.

EDUCATIONAL REQUIREMENTS:

• Placement as part of ongoing 3rd level education.

SKILLS/COMPETENCIES:

• Flexible, willing and positive attitude / mindset.

• Excellent verbal and written communication skills and attention to detail.

• Basic documentation & PC skills.