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Interim GMP Production Manager

Surrey
Posted 2 days ago
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Interim GMP Production Manager

Our client are looking to recruit an Interim GMP Production Manager to lead a small team delivering the aseptic GMP manufacture of clinical grade sterile products in their new facility.

You will be responsible for:

  • Final definition of SOPs, protocols, and policies currently in draft
  • The daily supervision of GMP production
  • Leading on technology transfer and scale-up work
  • Providing data for application to regulatory authorities
  • Maintaining, validating and controlling all aspects of the production process and environment

You will:

  • Enjoy working and developing a small team to achieve agreed goals on budget and to schedule
  • Be a strong team player with excellent communication skills (written and verbal) who is open, honest and inclusive
  • Use your knowledge and experience in GMP to inform and influence key stakeholders appropriately, building solid working relationships

Responsibilities include:

  • Writing, reviewing and implementing SOPs and batch records
  • Ensuring compliance with GMP principles and industry standard practices
  • Ensuring adherence to relevant legislation e.g. COSHH, Health and Safety at Work
  • Working alongside QA, ensuring all staff are trained in GMP
  • Ensuring budgets, schedules, facility capacity and performance requirements are met
  • Resolving complex problems by analysing situations or data that may be affected by multiple factors
  • Defining short and long term strategic GMP plans, implementing agreed actions
  • Line managing a small team
  • Managing and developing yourself, your direct reports and colleagues appropriately

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£35,000/yr

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Essential:

  • Several years’ experience working in an aseptic GMP environment
  • Strong current knowledge of GMP quality systems, standards and implementation including writing and reviewing SOPs, risk assessments, material risk assessments, equipment and process qualification and procurement
  • Experience of leading and managing a team, including line management
  • Knowledge of GMP validation and qualification requirements
  • Knowledge of health and safety compliance requirements
  • Knowledge of process improvement techniques
  • Technical appreciation of analytics/testing
  • Effective team player
  • Sound planning and organisational skills
  • Flexible approach to work
  • Strong written and verbal communication skills
  • Eye for detail
  • A willingness to continuously improve and share your own knowledge of GMP and developments in the industry

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Desirable:

  • Supervisory experience in an aseptic GMP facility
  • Experience of reviewing and approving batch records
  • Injectable sterile pharmaceutical formulation experience
  • Lyophilisation technical knowledge and experience
  • Experience of small molecule, cytotoxic materials and isolation techniques
  • Experience of initiating new GMP activities
  • Experience in clinical labelling and packaging of drug products
  • Experience of hosting regulatory and client inspections/audits
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Skills

GMP
Aseptic Manufacturing
SOP Writing
Team Leadership
Regulatory Compliance
Process Validation
Risk Assessment
Health and Safety
Problem Solving
Communication
Planning
Organizational Skills
Process Improvement
Analytical Skills
Training
Batch Record Review

Location

Surrey, England, United Kingdom

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