Section In charge / Assistant manager - Production Biochemistry

Job Description:

Min experience of 5-10 years in Production, R&D or formulation development activities.

Duties and Responsibilities

  • Propose and implement recommendations to increase efficiency, safety, and quality.
  • Support the progress of new product development projects
  • Ensure & control the production activities.
  • Ensure high standard of housekeeping and cleanliness in manufacturing area.
  • Monitor and control the yield losses during the production process.
  • Initiate plans to minimize manufacturing costs.
  • On line completion and reviewing of the batch records and documents.
  • Preparation & review of SOPs
  • Imparting on the Job training to executive and technician about the operations.
  • Coordinating with QA and QC for validation and in-process checks.
  • To maintain and monitor the cGMP standards
  • Requirements

  • Higher Educational background in Biochemistry, Microbiology, Biotechnology
  • Min experience of 5-10 years in Production, R&D or formulation development activities.
  • Have understandings of technical issues involved with production process
  • Prepare, and review of validation protocols & experiments
  • 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, 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 good manufacturing practices
  • Aseptic processes, Lean, OEE and similar KPIs.

  • Hands-on experience: US FDA, UK MHRA, ANVISA Brazil, TGA - Australia or MCC South Africa plant experience will be having an added advantage.

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