Production Operations Specialist

2 days ago

Vizag, Andhra Pradesh, India beBeeManufacturing Full time ₹ 4,00,000 - ₹ 8,00,000

Job Overview

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We are seeking an expert to oversee manufacturing and production operations, manage equipment, process validation, handle change controls, deviations, incidents, and ensure compliance with regulatory audits. Key responsibilities include creating SOPs (Standard Operating Procedure), providing training, and applying expertise.

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Responsibilities

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  • You will be responsible for handling line operations, specifically production and manufacturing activities like CIP (Cleaning-in-place), SIP (Sterilizing-in-place), and batch manufacturing.
  • You will be responsible for handling equipment like Steam Sterilizer, Dry heat sterilizer, HVAC (Heating, Ventilation, and Air Conditioning), water system, compressed air, Nitrogen system, etc.
  • You will be responsible for process validation for Sterilization, Washing, Aseptic filling, and cleaning procedures.
  • You will evaluate change controls, deviation, and incident, (OOS) out of specification, (OOT) out of trend, and risk management.
  • You will prepare the production process SOPs (Standard Operating Procedures) and batch records.
  • You will provide training on GMP (good manufacturing practices).
  • You will apply knowledge of aseptic processes, Lean, OEE (Overall Equipment Effectiveness), and similar KPIs (Key Performance Indicators).
  • You will respond to queries and questions regarding regulatory audits such as US FDA (Food and Drug Administration).
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Qualifications

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Educational Qualification

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A Bachelor's or Master's degree in Pharmaceutical Sciences, Chemical Engineering, or a related field is required.

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Minimum Work Experience

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7 years of experience in pharmaceutical manufacturing operations is essential.

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Skills & Attributes

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  • Expertise in line operations, especially in manufacturing activities like CIP, SIP, and batch manufacturing.
  • Proficiency in understanding equipment such as Steam Sterilizer, Dry heat sterilizer, HVAC, water system, compressed air, Nitrogen system, etc.
  • Understanding of Process Validation for Sterilization, Washing, Aseptic filling, and cleaning procedures.
  • Knowledge for evaluation of change control, deviation, incident, out of specification, out of trend, and risk management.
  • Experience in preparing production process SOPs and batch records.
  • Understanding and application of Aseptic processes, Lean, OEE, and similar KPIs.
  • Hands-on experience in regulatory audits, particularly with agencies like the US FDA.
  • Good understanding of GMP and good laboratories practice.
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Behavioral Skills

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  • Capacity to provide training on GMP and other relevant areas.
  • Collaborates seamlessly with cross-functional teams, promoting a cooperative and inclusive work environment.
  • Efficiently manages time to meet production schedules and deadlines without compromising quality.
  • Must have hands-on experience in sophisticated manufacturing machines and equipment.
  • Effective communication and training skills for user departments and service providers.
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