Operator Manufacturing Injectables

Amneal Pharmaceuticals LLC; India; On-site; INR 350,000 - 450,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad, India is seeking an aseptic manufacturing professional to oversee aseptic area activities, line clearances, machine operations, and documentation.

You will ensure GMP compliance, cGMP, SOP adherence, and qualification activities (IQ/OQ/PQ) for equipment, while maintaining hygiene and safety standards.

Qualifications

• B.Sc./Diploma/I.T.I with minimum 02-08 years of experience.

Responsibilities

• Responsible to perform and monitor all activities related to Aseptic area.
• Responsible to perform the cleaning and sanitization of machines, instruments and equipment’s and area.
• Responsible for line clearance activity before commencing the operations.
• Responsible to operate the machines filling, instruments and equipment’s of area.
• Responsible to fill all the records and logbooks related to aseptic manufacturing, filling, cleaning, DP and temperature monitoring.
• To manage the activities related to aseptic area like line clearances before any production activity, aseptic batch manufacturing activity, Filling activity and sanitization activity as applicable.
• Inform immediately to concern supervisor for any observation/disturbance found in the aseptic area.
• Responsible to update on self-hygiene, cleaning & sanitization of area, follow SOPs, filled the document, of area.
• Responsible to follow the preventive maintenance schedule of machines, instruments and equipment’s of area and to perform the preventive maintenance of the equipment.
• To follow the cGMP, Good Document Practice and discipline in the department.
• Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance.
• Responsible to ensure qualification and calibration status of equipment and instruments to avoid due/overdue.
• Responsible to attend the training as per schedule and to ensure the training and work as per TNI.
• Oversee machine operations, ensuring the adherence to Standard Operating Procedures (SOPs).
• Ensure product quality and compliance with SOPs, industry regulations, and customer specifications.
• To involved in the qualification (IQ/OQ/PQ) of equipment's i.e vessels, Ball mill, Dyno mill, Leak testing machine, DPB, Filling machine dispensing booth.
• Conduct routine cleaning, checks on equipment maintenance and ensure adherence to safety protocols.
• Handle production documentation, including batch records, and ensure accurate recording as per AlCOA +.
• Qualifications

Skills

Aseptic operations

Line clearance

Documentation practices

Education

B.Sc./Diploma/I.T.I

Job description

Responsible to perform and monitoring all the activities related to Aseptic area.

Responsible to perform the cleaning and sanitization of machines, instruments and equipment’s and area.

Responsible for line clearance activity before commencing the operations.

Responsible to operate the machines filling, instruments and equipment’s of area.

Responsible to fill all the records and logbooks related to aseptic manufacturing, filling, cleaning, DP and temperature monitoring.

To manage the activities related to aseptic area like line clearances before any production activity, aseptic batch manufacturing activity, Filling activity and sanitization activity as applicable.

Inform immediately to concern supervisor for any observation/disturbance found in the aseptic area.

Responsible to update on self-hygiene, cleaning & sanitization of area, follow SOPs, filled the document, of area.

Responsible to follow the preventive maintenance schedule of machines, instruments and equipment’s of area and to perform the preventive maintenance of the equipment.

To follow the cGMP, Good Document Practice and discipline in the department.

Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance.

Responsible to ensure qualification and calibration status of equipment and instruments to avoid due/overdue.

Responsible to attend the training as per schedule and to ensure the training and work as per TNI.

Oversee machine operations, ensuring the adherence to Standard Operating Procedures (SOPs).

Ensure product quality and compliance with SOPs, industry regulations, and customer specifications.

To involved in the qualification (IQ/OQ/PQ) of equipment's i.e vessels, Ball mill, Dyno mill, Leak testing machine, DPB, Filling machine dispensing booth.

Conduct routine cleaning, checks on equipment maintenance and ensure adherence to safety protocols.

Handle production documentation, including batch records, and ensure accurate recording as per AlCOA +.

Qualifications

B.Sc./Diploma/I.T.I with minimum 02-08 years of experience.

Job Info

• Job Identification 7111
• Locations Plot No.- 15,16,17, Pharmez Special Economic Zone (SEZ)|, Ahmedabad, GJ, 382110, IN
• Degree Level Diploma in Business Administration