Job highlights

- On line completion and reviewing of the batch records and documents

- Prepare the production process SOPs & batch records

- Knowledge for good manufacturing practices . Aseptic processes,Lean,OEE and similar KPIs

- Higher Educational background in Biochemistry,Microbiology,Biotechnology . 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 valuable 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.

📌 Section In charge / Assistant manager - Production Biochemistry (Surat)
🏢 Arkray Healthcare
📍 Surat