About this role

  • Posted on

  • Location

    Oxfordshire

  • Salary

    £25000.00 - £30000.00 per annum

  • Type

    Permanent

  • Division

    Pharmaceutical Manufacturing Jobs

  • Reference

    BBBH18479UK_1620723611

  • Start date

    ASAP

  • Managing this role

Consultant

Urszula Kaldi

+44 (0) 203 8543 089

urszula.kaldi@xplorepharma.com

154-158 Shoreditch High Street

Description

Responsibilities

  • To be accountable and responsible for all associated activities in the absence of the Section Head.
  • Ensure all team members are multi skilled to perform tasks, effectively, safely and in compliance of procedures. Effectively utilise the resource across the business to minimise increases in headcount.
  • Deliver the weekly production schedule by ensuring, skills, materials, components, equipment, and documentation are available on time and in full.
  • Have a detailed knowledge and understanding of products and processes to enable improvement and Lead and support client and regulatory visits and inspections.
  • Be accountable for ensuring all associated batch documentation is completed in real time, undertake frequent daily routine checks and ensure all BMR entries are compliantly completed (including all SAP transactions).
  • Agree measures of performance and targets with the Section Head, the targets will be cascaded appropriately.
  • Embrace and undertake an active role in Mini T and Operational Excellence and support the implementation of continuous improvement initiatives and ideas.
  • Support the introduction of new products, equipment, and processes.
  • Be accountable and responsible for ensuring deviations and CAPAs are effectively closed on time.
  • Ensure the facility is appropriately kept clean and tidy in line with 5s principles.
  • Identify opportunities to Lean the process, eliminating or reducing waste and or non-value adding activities.
  • Coach and mentor staff to ensure products are manufactured and documentation completed in accordance with GMP, Standard Operating Procedures and other regulatory agency requirements.
  • Timely completion of relevant deviation and complaint investigations to identify true root cause. Along with timely closure of corrective/preventive actions for deviations, complaints and GMP audits that are assigned to them with a focus on improved processes, documentation, documentation completion and training.
  • Completion of Level 1 & 2 audits.
  • Ensure aseptic licence, as required, is kept up to date.
  • Ensure compliance with environment, 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 working in a production operation and GMP experience
  • Technical writing skills – Deviations, reports, investigations, SOPs.
  • Leadership experience and supervisory management qualifications, preferably to NVQ level 3 or equivalent.
  • Lean manufacturing and/or Lean Six-Sigma training and experience desirable.
  • Able to work across a 24/7 or Double Days shift pattern, including weekends.

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