Officer, Manufacturing Process Operations

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

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad, Gujarat seeks a Manufacturing Supervisor to oversee the manufacturing, processing, packaging and holding of drug products in line with defined procedures for stability and commercial batches.

The candidate should hold a BE/B.S. (or BA/BS) and M.Pharm is preferred, with 2–5 years of experience in a cGMP environment. On-site role, strict SOPs, batch records, and staff training are required.

Qualifications

• Bachelor's degree in BA/BS or BE required.
• M.Pharm preferred.

Responsibilities

• Supervise manufacturing, processing, packaging and holding of drug products.
• Maintain area and equipment per cGMP in good repair and sanitized condition.
• Perform online documentation of departmental procedures.
• Train operators on operation and cleaning SOPs.
• Coordinate IQ/OQ for new equipment or systems.
• Perform PQ for new equipment/systems.
• Follow all departmental SOPs for day-to-day operations and cleaning.
• Handle and manage material movement per defined procedures and batch records.
• Review and implement Batch Manufacturing Records, Batch Packaging Records, Process Study Protocols/Reports and related documents.
• Follow safety rules and departmental instructions.
• Perform other duties as assigned by HOD.

Skills

2-5 years experience

Education

Bachelor's degree (BA/BS) or BE

M. Pharm

Job description

Job Description

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

Job Responsibility

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

Qualifications

• Bachelors Degree (BA/BS) B.E. - Required
• M. Pharm M. Pharm - Preferred

Experience

• 2 years or more in 2 - 5 Years