Officer, Manufacturing Process Operations

Amneal Pharmaceuticals LLC; Gujarat; On-site; INR 350,000 - 550,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Gujarat is seeking a supervisor to oversee manufacturing, processing, packaging and holding of drug products in line with defined procedures and cGMP.

You will maintain clean, organized facilities, perform online documentation, train operators on SOPs, coordinate IQ/OQ and PQ for new equipment, ensure compliance with safety rules, and manage material movement according to batch records.

Responsibilities

• Supervision of manufacturing, processing, packaging and holding of drug product per defined procedures.
• Maintain area and equipment in orderly, cGMP-compliant, sanitized condition.
• Perform online documentation for departmental procedures.
• Impart training on operation and cleaning related SOPs to subordinates and operators.
• Coordinate IQ/OQ for new equipment/systems.
• Perform PQ for new equipment/systems.
• Follow all SOPs for day-to-day operations and cleaning.
• Handle and manage material movement per BMR/BPR.
• Review, execution and implementation of Batch Manufacturing Records, Batch Packaging Records, Process Study Protocols/Reports and all relevant documents.
• Adhere to safety rules and departmental general instructions.

Job description

Job Responsibility:

Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches.

Maintaining the area and equipment in orderly manner as per cGMP requirements in a good state of repair and sanitized condition.

To perform online documentation with respect to departmental procedures as per good documentation.

To impart training of operation and cleaning related SOP to all subordinates and operators.

Co-ordination for IQ / OQ for any new equipments / system.

To perform PQ for any new equipments / system.

To follow all concern departmental SOPs for day to day operation and cleaning.

To handle and manage material movement as per defined procedure and approved Batch Manufacturing Record / Batch Packing Record.

Review, execution and implementation of Batch Manufacturing Records, Batch Packaging Records, Process Study Protocols, Process Study Reports and all relevant Documents.

To follow all safety rules and departmental general instructions.

To perform workother than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.