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Job Description
- Plan the production budget for employment needs, materials needs, and tools needs.
- Ensure cGMP procedures are reviewed and that staff is training on relevant curricula
- Facilitate technical transfer of company processes to manufacturing. Review and approve batch records, change controls and project plans
- Coordinate with different departments to ensure the production priorities and ensure that the required raw material is available to deliver products in time.
- Supports investigations and is involved with CAPA recommendations
- Delegate or lead the writing of deviations, planned variance, change control forms or CAPAs as required
- Participate in production and planning meetings as requested
Job Requirements
- Bachelor’s in pharmaceutical science
- Minimum of 5 years’ experience in the sterile ampule and vile manufacturing
- Experience with lyophilizes operation
- Ability to make decisions and work with minimal to moderate supervision.
- Strong planning, organization and multitasking skills
- Solid understanding of applicable regulatory requirements
