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Interim GMP Production Manager

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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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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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