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