Section In charge / Assistant manager - Production Biochemistry

ARKRAY; Surat; In loco; INR 600.000 - 900.000; Tempo pieno

Descrizione del lavoro

A pharmaceutical company in Surat is seeking a professional with 5-10 years of experience in Production or R&D. The candidate should have a strong educational background in Biochemistry, Microbiology, or Biotechnology. Responsibilities include supporting product development and ensuring high manufacturing standards. Experience with regulatory requirements is a plus. Applicants should provide a full name, gender, university name, and CV when applying.

Competenze

• 5-10 years of experience in Production, R&D, or formulation development.
• Understanding technical issues in the production process.
• Hands-on experience with FDA regulations.

Mansioni

• Propose and implement recommendations to increase efficiency.
• Support new product development projects.
• Ensure control of production activities.

Conoscenze

Experience in Production

Knowledge of cGMP standards

Technical understanding of production processes

Experience with US FDA regulations

Understanding of Aseptic processes

Formazione

Higher Education in Biochemistry

Higher Education in Microbiology

Higher Education in Biotechnology

Strumenti

Steam Sterilizer

Filling Machine

Lyophilizer

Descrizione del lavoro

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

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