An exciting Opportunity has come up for a Graduate to join our clients Pharma business in Penicuik.This role is for a GMP Production Scientist to join our Manufacturing Team. As part of the team, this role will contribute to the delivery of a variety of projects within the necessary time constraints to cGMP standards.
Responsibilities:
Reporting to the GMP Production Supervisor, the main responsibilities of the role include:
• Scale-up, processing, validation, and accurate completing of batch documentation for manufacturing campaigns within scheduled time frames and to quality standards.
• Review and maintain equipment.
• Liaise with the Procurement team to ensure that materials and consumables are available in line with the production schedule.
• Assist with the general running and monitoring of the clean room facility, including maintaining its cGMP compliance and MHRA licensed status.
• Adhere to company Quality and Health & Safety policies.
• There is a requirement to work shift patterns periodically, with ample advance notice.
Skills/Experience Required:
Essential:
• BSc/HND qualification in a relevant scientific discipline (microbiology/biochemistry/chemistry graduates would be of particular interest)
• Alternatively, appropriate experience working within a relevant regulated environment, e.g. GLP, GMP, ISO/IEC 17025.
• Good working knowledge of Microsoft Office applications, in particular, Word and Excel.
Desirable:
• Industry experience in a cGMP compliant organisation carrying out downstream processing and purification of proteins would be a distinct advantage.
• Experience in writing and completion of quality documentation, i.e. batch records, SOPs, IQ/OQ/PQ, risk assessments and deviations etc.
• Practical knowledge of aseptic techniques gained working within a cleanroom environment.
• Familiarity with carrying out environmental monitoring for viable and non-viable particles.
Personal Attributes:
• Enthusiastic with a ‘can‐do’ attitude.
• Excellent team player, but also has the ability to work unsupervised.
• Good organisational and communication skills with a good level of English (written and verbal) and numeracy skills.
• Attention to detail with legible handwriting.
• Committed to upholding high standards of working and able to closely follow process procedures.
• Ability to multitask and learn new techniques. • Flexible attitude to changing process priorities
