Packaging Operator and Visual Inspector- Shift Work - Swindon, United Kingdom - Thermo Fisher Scientific

Tom O´Connor

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Tom O´Connor

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Description

The Role:

We are hiring 2 operators to join the team onsite in Swindon. This role does involve shift work and manual work.


Position Summary:


  • To set up, clean and operate the production lines used for labelling and packaging process in accordance with Standard Operating Procedures (SOPs) and Batch Manufacturing Records (BMRs).
  • To carry out visual inspection of manufactured products within production.

Responsibilities:


  • Completion of BMRs, online review of GMP work and real time reconciliations. Support the closure of BMRs.
  • Cleaning of area/equipment in accordance with SOPs, cGMP and pharmaceutical industry regulatory standards. Ensuring areas are always audit ready.
  • Monitoring equipment status and readiness for Automated Visual inspection, Manual visual inspection, and packaging operations reporting any faults or issues to Supervision.
  • Ensure work and documentation is completed in accordance with cGMP, Standard Operating Procedures, and other regulatory agency requirements.
  • Align with cGMP requirements and company rules, policies, and procedures.
  • Maintenance of competency (suitably qualified and experienced) for the role through timely completion of training and, as appropriate, delivery of skills and knowledge training to others.
  • Always maintain a high level of tidiness and cleanliness personal, work area and department using 5S and lean tools.
  • Contribute towards continuous improvement initiatives both through participation and putting forward ideas and suggestions.
  • Support the closure of QRs, CAPAs, OOS, CCs and EHS actions when required by supervisors.
  • Maintain a vision test for manual inspection of products. Be fully trained to perform manual/semiautomated visual inspection, AQL inspection, product sampling and packing for all products manufactured onsite.
  • Support project validation work and where appropriate new product introduction to the Operations department
  • Set equipment to ensure minimum downtime levels, minimum product damage/waste, support process startup, changeovers, testing and cleaning activities in accordance with SOP's and cGMP requirements.
  • Operation of airlocks and cleaning systems to ensure that all equipment is ready for use.
  • Assist where appropriate in basic equipment maintenance.

EH&S:


  • Understand emergency procedures and align with safe systems of work.
  • Ensure compliance with environment, health and safety and security policies and procedures, rules, signage, and instructions always.
  • Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

Minimum Requirements/Qualifications:


  • Experience of working in a pharmaceutical, or other regulated environment (MHRA and FDA regulations)
  • Desirable
  • Experience of clean room working, an understanding of aseptic manufacturing and filling
  • Desirable
  • Good communication skills.
  • Passionate about quality and customer service.
  • Good standout colleague, organised, accurate and strong documentation skills.
  • Participate in continuous process improvement.
  • Has the skills to work methodically.
  • Has good eyesight and is not colour blind.
  • Patience to inspect products to a consistently high level.
  • GCSE level Maths and English (or equivalent)Able to handle material up to 5kg with reasonable adjustments if required.
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