Job Description
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 Surat About In order to apply to this job, please press [] button below, and provide us your Full name, Gender, University name and attached CV. In the title section write down the position you are applying! We will be waiting to hear from you soon
Employement Category:
Employement Type: Full time
Industry: Medical / Healthcare
Role Category: Medical / Healthcare
Functional Area: Not Applicable
Role/Responsibilies: Section In charge / Assistant manager
Keyskills:
Production
RD
Formulation Development
Biochemistry
Microbiology
Biotechnology
Process Validation
Change Control
Risk Management
Lean
OEE
US FDA
Technical Issues
Validation Protocols
Equipment Handling
Good Manufacturing Practices
Aseptic Processes
UK MHRA
ANVISA Brazil
TGA Australia
MCC South Africa