Officer, Manufacturing Process Operations

Amneal Pharmaceuticals LLC; Ahmedabad; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks a competent manufacturing operations supervisor to oversee the supervision of manufacturing, processing, packaging and holding of drug products in line with defined procedures for stability and commercial batches.

The role ensures cGMP-compliant housekeeping, online documentation, operator training on SOPs, coordination for IQ/OQ for new equipment, PQ testing, adherence to batch records, and safe, efficient material movement.

Responsibilities

• 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.

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.