Team Member – Packing

SupportFinity™; Visakhapatnam; On-site; INR 1,200,000 - 1,500,000; Full time

Job summary

SupportFinity™ is looking for a candidate to oversee manufacturing and production operations, ensuring compliance with regulatory audits and managing equipment. Responsibilities include creating SOPs, providing training, and applying expertise in aseptic processes.

The ideal candidate will have a Bachelor’s or Master’s degree in Pharmaceutical Sciences or Chemical Engineering and at least 7 years of experience in pharmaceutical manufacturing operations, with strong communication and training skills.

Qualifications

• 7 years of experience in pharmaceutical manufacturing operations.
• Hands-on experience with regulatory audits, particularly US FDA.
• Expertise in creating SOPs and training on GMP.

Responsibilities

• Manage production and manufacturing operations, including CIP and SIP.
• Handle process validation and evaluate change controls.
• Prepare SOPs for production processes and provide GMP training.

Skills

Manufacturing activities (CIP, SIP, batch manufacturing)

Understanding equipment (Steam Sterilizer, HVAC)

Process Validation

Evaluating change control and risk management

Knowledge of GMP and good laboratory practices

Training skills on GMP

Effective communication

Education

Bachelor’s or Master’s degree in Pharmaceutical Sciences or Chemical Engineering

Tools

Steam Sterilizer

Dry heat sterilizer

HVAC

Water system

Compressed air system

Nitrogen system

Job description

Job Summary

We are looking for a candidate to oversee manufacturing and production operations, managing equipment, process validation, handling change controls, deviations, incidents, and ensuring compliance with regulatory audits. Responsibilities include creating SOPs (Standard Operating Procedures), providing training, and applying expertise.

Responsibilities

• 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).

Qualifications

Educational Qualification
A Bachelor\u2019s or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, or a related field

Minimum Work Experience
7 years of experience in pharmaceutical manufacturing operations

Skills & Attributes

Technical Skills

• 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.

Behavioural Skills

• 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.