Team Member - Manufacturing (Peptide)

Job Summary We are looking for an individual to ensure strict adherence to safety protocols, SOPs, and quality standards, ensuring batch manufacturing activities, coordinating with various departments to maintain operational efficiency.

The role involves executing production activities, coordinating with cross-functional teams and meeting production targets.

Roles & Responsibilities You will be responsible for adherence to company safety norms, policies, and SOPs (Standard Operating Procedures).

You will execute batch manufacturing activities according to e-BMR instructions and workflow, ensuring submission of executed e-BMR and workflows to IPQA (In-Process Quality Assurance) department.

With support of the MSAT and IPDO team execute trial, validation and commercial batches.

Your role involves coordination with other departments such as warehouse, QC (Quality Control) and others.

You will be accountable for timely completion of calibration, preventive maintenance activities, and reducing production breakdown time through coordination with shift in-charge and engineering department You will initiate quality notification, breakdown notification You will involve in commissioning and qualification activities of the equipment You will ensure qualification, validation, calibration of equipment, and process validation are done as per schedule and requirements.

You will ensure clean room practices are followed as per the SOP and maintain as per the desired conditions You will be responsible for maintaining overall operating area to meet current regulatory compliance and norms

Educational qualification : An B.Sc/ M.Sc (Analytical/ Organic Chemistry) Minimum work experience : 2 to 5 years Experience Skills & attributes: Technical Skills Operation of critical equipment like reverse phase chromatography, Micro-wave reactor, Lyophilizer Ensuring the OEE of the equipment and utilization Proficiency in utilizing MES software to execute batch manufacturing activities and ensure compliance with e-BMR instructions.

Understanding of Quality Management Systems, including SOPs, URS and protocols, to ensure adherence to quality standards.

Familiarity with SAP software for initiating quality notifications, breakdown notifications Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) to ensure compliance with regulatory requirements and quality standards.

Experience in executing the qualification, validation, and calibration of equipment, as well as process validation activities, ensuring adherence to schedule and regulatory requirements.

Behavioural skills Keen leaner and implement what has been learnt and ensuring adherence to safety norms and quality standards.

Effective communication skills to communicate with various departments, ensuring seamless collaboration and alignment of activities.

Capacity to identify and address production-related issues promptly.

Ensure timely completion of calibration, preventive maintenance and other operational activities.

Commitment to maintaining current regulatory compliance and adherence to norms to uphold product quality and safety standards.