General Responsibilities
- To comply with all Good Manufacturing Practice regulations and carry out all duties whilst maintaining good Health & Safety practices.
- To provide support to other departments and production teams as and when required
- Read & follow Standard Operating Procedures (SOPs)
- To complete all necessary documentation to GMP standards
- To perform specifics ‘set up’ in Grade C for all products
- To operate VHP for ‘set up’ vials and other components and materials into Grade B/A
- To manufacture all specific product types in Grade B/A and ensure manufacture within 5 days
- To manufacture all specific product types in Grade C
- To carry out clean down procedures prior and post manufacturing.
- To perform service function for team members when they are manufacturing in Grade A or Grade C.
- To deliver batches in line with daily production schedule.
- To transfer completed batches out of clean suites
- To perform work as directed accordingly by Supervisor/Manager.
- To carry out production activities in a compliant manner following batch records and SOPs
- To complete all necessary documentation to GMP standards: Batch records, log books
- Working areas to be kept clean and tidy at all times in line with GMP
- Knowledge and understanding of stock control
- To follow and complete batch records with no missing data
- To deliver environmental plates and samples to Quality Control (QC).
- To understand FMS system and follow signals
- To alert any problems to team, Supervisor/Manager or Quality Assurance (QA)
- To understand and ensure batch records are fully completed when work is finished
- Wear appropriate clothing in unclassified, Grade C and Grade A/B areas.
- Undergo environmental monitoring and gowning assessment
- To assist with stock checks and stock control
- Remove expired stock from clean suite in line with procedures
- To prepare components/sundry items for transfer from corridor into Grade C via transfer hatch in line with procedures
- Tropos check of batch records
- To train team members
- Previous experience of a production environment is desirable but further training will be given.
- Previous experience of GMP desirable.
- Scientific knowledge
- Good standard of written and oral English and Maths
- Computer literate
- Ability to work and perform in a team.
- Flexible and proactive approach to task and duties.
- Show initiative and self-motivation.
- Customer focussed approach to work.
- Willingness to take on extra responsibilities when required.
- GMP focussed approach to production activities and be able to show meticulous attention to detail.
- To be able to work and react to targets and deadlines.
- Able to demonstrate good written and verbal communication skills, and good standard of numeracy
- Work neatly and methodically
- Demonstrate a ‘what’s next’ mentality
To discuss this role further, please apply or contact nicole.cooper@nextphaserecruitment