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Head of Operations

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360 Resourcing Solutions

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Location:
United Kingdom

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Category:
Pharmacy

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Contract Type:
Not provided

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Salary:

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Job Description:

The Head of Operations is responsible for leading all Production and Warehouse activities within Quantum Aseptic Services. The role acts as the Head of Production as defined under EudraLex Volume 4, Chapter 2, and is accountable for ensuring that products are manufactured and stored in accordance with GMP, approved documentation and regulatory requirements to achieve the required quality standards.

Job Responsibility:

  • Lead day-to-day aseptic manufacturing and warehouse operations
  • Ensure safe, efficient and compliant production of aseptically prepared parenteral products
  • Develop and implement operational strategy aligned with corporate goals
  • Monitor and report KPIs relating to safety, quality, delivery and cost
  • Ensure products are produced and stored according to approved documentation and GMP requirements
  • Approve production instructions and ensure strict implementation
  • Ensure production records are reviewed, evaluated and signed by authorised personnel
  • Ensure departmental premises, utilities and equipment are qualified, maintained and fit for purpose
  • Ensure appropriate process validation, revalidation and qualification activities are completed and maintained
  • Ensure contamination control strategies are implemented, particularly for aseptic and cytotoxic operations
  • Joint ownership of the Pharmaceutical Quality System (PQS)
  • Approval of controlled documents and amendments relating to operations
  • Monitoring of environmental controls and cleanroom performance
  • Ensuring plant hygiene standards are maintained
  • Participation in validation strategy and oversight of validation activities, including as part of service and strategy improvements
  • Approval and monitoring of suppliers and outsourced GMP-related service providers
  • Designation and monitoring of storage conditions for materials and finished products
  • Monitoring compliance with GMP and GDP requirements
  • Participation in deviation investigations and quality issue escalation
  • Participation in management review and advocacy for continual improvement
  • Ensure structured GMP training programmes are established and maintained
  • Approve departmental training programmes and ensure effectiveness is assessed
  • Ensure specific contamination control training for aseptic and cytotoxic environments
  • Ensure compliant storage and distribution of materials and finished products
  • Maintain GDP compliance for finished product logistics
  • Monitor stock control, inventory accuracy and environmental conditions
  • Ensure supplier qualification and performance monitoring

Requirements:

  • Degree in Pharmaceutical Sciences, Engineering or related discipline is desirable
  • Minimum 10 years’ pharmaceutical manufacturing experience
  • Minimum 5 years senior leadership experience in sterile or aseptic manufacturing
  • In-depth knowledge of EU GMP (EudraLex Vol 4), MHRA and ICH guidelines
  • Experience in cytotoxic or highly potent product handling
  • Strong leadership, communication and regulatory inspection experience
What we offer:
  • Pension
  • Free food and drink at work
  • Strong Social Committee

Additional Information:

Job Posted:
March 01, 2026

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