We are looking for individuals to carry out day to day operations of a sterile GMP filling facility. We are currently building a new purpose-built facility you will have the opportunity to join at the beginning of the project and be part of the initial set up involved in the validation and qualification of the building and equipment. You will have the opportunity to be cross functional taking part in validation activities and working closely with QA and QC.
- 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
- Support for the sterile Team Leader at weekly meeting, KPI’s, planning and deviation investigations
- Ensure compliance with all regulatory requirements and maintain excellent GMP, quality control and safety
- All activities to be carried out in compliance with cGMP, with an excellent attention to detail and accuracy for all paperwork
- Use previous experience to support and coach the team on the shop floor as well as supervise daily workloads
- 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.
- Preparing autoclave and washer loads in accordance to proccedure
- 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
- Change control owner and help with investigator and deviations
- Knowledge of Six Sigma or Lean manufacturing and implementing continuous improvements
Experience/Skills needed to fulfil the role
- Minimum of 3 years GMP experience in a production environment with experience of sterile production and demonstrated aseptic techniques
- At least 2 years experience in manufacturing
- Experienced in Clean Room Grade A environments, Isolators or RABS
- Should be assessor or qualified in a safety systems, i.e. COSHH, Risk assessments, Manual handling or IOSH managing
- Experienced working with Excel and Word
- Knowledge of lean production or six Sigma (green belt)
- Evidence of excellent attention to detail and ability to follow Standard Operating Procedures
- Experience in overseeing validation operation of equipment and participation of SAT’s or FAT’s