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This position is in our client's facility producing antigens derived from large scale anaerobic fermentations. After concentration and purification, antigens are blended as the active ingredient in our pig, cattle, sheep or chicken vaccines.
Job Responsibility:
Perform Direct associated tasks with the manufacture of intermediates (media & antigen) per the Production Schedule and in accordance with local Regulatory and GMP requirements
Review and verify product batch records for accuracy of entries, compliance to established limits, specifications and the presence of all verification signatures
Follow standard operating procedures and ensure Good Documentation Practices
Prepare, sterilize and stage laboratory consumables required for manufacturing
Apply MPS tools and methodology to lead and support investigations and CAPA implementation
Requirements:
Experience in an aseptic/ cleanroom environment preferred
Experience using SAP
Working knowledge of cGMP and inventory control concepts
Previous experience working towards SOP's
Experience in large scale bacterial antigen processing