MSAT Technician

MSAT Technician - Pharmaceutical - Cambridge - Contract

Our client is a leading pharmaceutical manufacturer. At present, they are seeking an MSAT Technician on a temporary contract basis for 4 months at their facility in Cambridge.

Overview:

• Day to day activities in a sterile manufacturing facility, filling of sterile products, autoclaving and washing of components.
  
  
• Maintaining the facility to GMP standards of cleanliness and environmental standards.
  
  
• Ensuring all paperwork is completed to GMP standards and non-conformity documentation and investigation
  
  Key Responsibilities:
  
  
• Ensure compliance with all regulatory requirements and maintain excellent GMP, quality control and safety.
  
  
• Excellent attention to detail and accuracy, all paperwork to be completed accurately and in a timely manner compliant with cGMP.
  
  
• Support the sterile Team Leader at weekly meeting, KPI’s, planning and deviation investigations
  
  
• Experienced in working in a sterile environment, an isolator or RABS unit (Grade A).
  
  
• Work with single use sterile technologies, and closed systems
  
  
• Demonstrate ability to build bonds and work with other departments QA, QC, Validation etc.
  
  
• Prepare autoclave and washer loads in accordance to procedure
  
  
• Write and review new SOP’s and Batch records and roll these out to the team
  
  
• Have the flexibility to operate in all areas of production, sterile operation, validation equipment, cleaning and autoclaving
  
  
• On-going cleaning, environmental monitor and building compliance
  
  
• Investigate any deviations and action CAPA’s
  
  
• Perform regular cleaning of the cleanroom to ensure it remains within GMP standards.
  
  
• Perform stock management tasks within the warehouse.
  
  Candidates will ideally have GMP experience in a production environment with experience of sterile production and demonstrated aseptic techniques.
  
  Additional skills:
  
  
• Experience in GMP manufacturing.
  
  
• Experienced in Clean Room Grade A environments, Isolators or RABS.
  
  
• Should be assessor or qualified in safety systems, i.e. COSHH, risk assessments, manual handling or IOSH Managing Safely.
  
  
• Experienced working with Excel and Word.
  
  
• Knowledge of lean production or six Sigma.
  
  
• Evidence of excellent attention to detail and ability to follow Standard Operating Procedures.
  
  
• Experienced in writing SOPs for cleanroom activities.
  
  
• Knowledge of validation operations, such as; FATs, SATs and IOQ/PQ