Shift Leader Aseptic (Sterile working environment)

Start Date: ASAP

1. General Responsibilities

  • To oversee and perform line set ups peristaltic pump operation and clearance safely and correctly as stated in the relevant SOP’s.
  • To oversee all production staff and agency staff within classified aseptic and unclassified areas in which they are responsible
  • Ensure staff are aware of their role on that line
  • Oversee training requirements of production lead operators and operators
  • Quality of the product produced is to the company standard required.
  • GMP regulations are always adhered to.
  • Ensuring a high level of H/S is maintained throughout the production facility ensuring and correcting manual handling activities.
  • KPI measuring and driving production targets to ensure optimum performance
  • Planning and maintaining holiday cover and entitlement to ensure production operations remain on time and in full
  • Develop, train 5s throughout the facility
  • Lead and promote continuous improvement

2. Planned & Reactive Maintenance under supervision of the Production manager, Operations Manager, Engineering manager, Site Engineer and Engineering contractor.

  • Perform basic preventative & reactive maintenance
  • Schedule planned preventative maintenance and liaise with maintenance contractors as when required
  • Carry out and oversee basic repair work as and when required
  • Carry out basic and oversee planned maintenance activities
  • Schedule work following production schedule, method, production plan/ criteria and test functions.

3. Line Set Ups and Clearance activities.

  • Lines are set up to the specified SOP, schematic work instructions relating to the activity being performed
  • Line Clearance activities are performed as per company cGMP guidelines and related SOP’s
  • All machine parts are clean/ sanitised and labelled before and after use.
  • Quality incidents are reported to the QA/ Supervisor and recorded on the appropriate documentation
  • Check all documentation IPC’s batch docs are complete in a timely and correct manner at each stage of the process ensuring the documents meet with the principles of ALCOA ensuring data integrity.

4. Machine operation – All machine operation to include:

  • Oversee stopping and starting of all liquid fill and cap machines correctly and safely as per the SOP
  • Oversee and safe removal of product from the liquid fill and labelling machines
  • Reporting machine breakdowns to senior staff / engineers if unable to rectify the problem
  • Safe operation and set up of the liquid fill and labelling machines, as per the SOP’s.

5. Palletising finished product correctly, duties and responsibilities are:

  • Ensuring the correct plan and quantity are being placed onto the correct size pallet
  • Checking of shipper labels and their location are correct
  • Shipper quantities are as specified on the labels and quality of the product has not been compromised

6. In-process quality checks – duties and responsibilities include:

  • Checks are completed to the standards set out in the SOP
  • All checks are completed in a timely manner and documented correctly to GMP standards
  • Any quality issues are reported to the senior management, QA assist QA with change controls, deviations, corrective action, preventative action and root cause investigation
  • GMP activities within the manufacturing unit
  • Cleaning of facility and equipment as per SOP or work instruction

7. General duties and tasks as and when required.

  • Any another reasonable work-related task
  • Any other cross functional work-related tasks

Preferred qualification, cGMP industry standard recognised training qualification

GCSE or equivalent Maths & English

Job Types: Full-time, Permanent

COVID-19 considerations:
The company has a comprehensive COVID-19 programme

 

All applications must be supported by a CV and sent to careers@originltd.com 

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