AVI & Pack Operator
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Working shift pattern: 24/7 - rotating day and night shift
When youre part of Thermo Fisher Scientific youll do challenging work and be part of a team that values performance quality and innovation. As part of a successful growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry we give our people the resources and opportunities to make significant contributions to the world.
Responsibilities:
Set up and operation of the Automatic visual inspection & packing lines in accordance with Standard Operating Procedures (SOPs)
Perform AVI and packing of pharmaceutical products (Sterile & non-sterile) in accordance with Standard Operating Procedures (SOPs) and Batch Manufacturing Records (BMRs)
Perform AVI and Packaging operational duties e.g. line clearance In Process Checks (IPC) checks replace components on line complete batch & associated documentation right first time for accordance with SOPs to ensure compliance with cGMP
Set equipment to ensure minimum downtime levels minimum product damage/waste support machine start-up changeovers testing and cleaning activities in accordance with SOPs and cGMP requirements
Monitoring equipment status and readiness for inspection & packing reporting any faults or issues to Supervision
Cleaning and maintenance of clean rooms/equipment to SOPs cGMP and pharmaceutical industry regulatory standards
To ensure any instances of non-conformance are communicated to the Process Coordinator Area Manager or Quality Assurance representatives to ensure that they are investigated and rectified
Support project validation work and new product introduction to the Operations department
Using Quality systems for GMP changes and report writing.
Conduct and assist where appropriate in basic equipment maintenance
GMP:
Ensure products are inspected and packed and documentation is completed in accordance with GMP and Standard Operating Procedures.
Support the Process Coordinator in performing Level 1 audits.
Support relevant Deviation and Complaint investigations and determination of appropriate CAPA as required.
Maintain a high level of tidiness and cleanliness at all times personal work area and department.
Take ownership accountability and enforce good GMP and GDP within the GMP facility.
EH&S:
Understand emergency procedures and comply with safe systems of work.
Ensure compliance with environmental health and safety rules signage and instructions at all times.
Ensure prompt reporting and investigation of all accidents near misses and breaches of rules.
Qualifications/Experience:
Experience in clean room working knowledge of AVI packaging and serialization is highly desirable
Strong competency in English and Maths is essential and a scientific background is essential (e.g. A-Levels)
Excellent communication and teamwork skills with the ability to manage your own workload
Understanding of HMI-driven pharmaceutical systems
At Thermo Fisher Scientific each one of our 120000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more