Assistant manager / Sr. Executive - Production Sterile

Job Description:

Educational background in Pharmacy. Min 5 years of experience in Production department.

Requirements

  • Higher Educational background in Pharmacy
  • Min 5 years of experience in Production department in Aseptic operations
  • Understanding of equipment like Steam Sterilizer, Dry heat sterilizer, Washing Machine, Filling Machine, Lyophilizer, HVAC, water system, compressed air, Nitrogen system etc.
  • Understanding on Process Validation for Sterilization, Washing, Aseptic filling, and cleaning procedures.
  • Knowledge for evaluation of change control, deviation, and incident, out of specification, out of trend and risk management.
  • Prepare the production process SOPs & batch records
  • Knowledge for goods manufacturing practices and capacity to provide the training to all concerns.
  • Knowledge on Aseptic processes, Lean, OEE and similar KPIs.

  • Hands-on experience for any of regulatory audits such as US FDA, UK MHRA, ANVISA Brazil ,TGA - Australia or MCC South Africa plant experience will be having an added advantage.

    Duties and Responsibilities

  • To control the production activities
  • To ensure schedules are adhered to commitments
  • To ensure high standard of housekeeping and cleanliness in low bio burden area.
  • To ensure that production is done as per defined procedure & specifications
  • To monitor and control the yield losses during the production process.
  • Initiate plans and processes which minimize manufacturing costs
  • On line completion and reviewing of the batch records and documents.
  • Preparation & review of SOPs of the production sterile operations
  • Imparting on the Job training to executive and technician about the sterile operations.
  • Coordinating with QA and QC for validation and in-process checks and approvals.
  • Office Location

      

    Surat

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