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.
Office Location
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