Associate - Manufacturing & Packing

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 180,000 - 300,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a professional for a role in the sterile manufacturing department. The candidate will ensure training per schedule and follow SOPs for the general area, with emphasis on maintaining GMP-compliant records and procedures.

Responsibilities include preparing and reviewing SOPs, managing BPRs/BMRs, and overseeing deviations, CAPA, and change control processes to ensure manufacturing quality and compliance.

Qualifications

• ITI / B.Sc / Diploma
• Knowledge of GMP practices and regulatory norms (USFDA, EU, WHO).
• Experience with BMRs/BPRs, deviations, CAPA and change control.

Responsibilities

• Attend and ensure training as per training schedule and TNI.
• Work according to SOPs in sterile manufacturing department.
• Prepare, review, revise and control SOPs for General Area in Sterile Manufacturing.

Skills

GMP compliance

Regulatory knowledge

BMR/BPR processing

Deviations & CAPA

Changeovers

Tooling for packaging

Education

ITI / B.Sc / Diploma

Job description

Job Description

• Attend and ensure the training as per training schedule and TNI
• Attend and ensure the training as per training schedule and TNI
• Work according to standard operating procedures in sterile manufacturing department
• Prepare, review, revise and control the Standard Operating Procedures of General Area in Sterile Manufacturing Department
• Prepare BPR
• Validate and calibrate all equipment and lines
• Record and check all the logbooks related to general area and equipment of packaging and inspection area
• Train all the subordinates, technicians and operators of the department
• Comply with cGMP, Good Document Practice and departmental discipline
• Handle document of Packing and Inspection
• Monitor all the activities related to packing and inspection
• Responsible for line clearance activity before commencing the operations
• Responsible to follow the preventive maintenance schedule of machine
• Responsible for cleaning and sanitization of visual inspection and Packing area.
• Responsible to operate the machines .
• Responsible to fill the log of general area as per SOP and work execution. Responsible to follow cGMP, GDP, and discipline in the department and to ensure that all employees follow the same.
• Responsible to ensure that all equipment’s and lines are in validated and calibrated status.
• Responsible to prepare daily production report as per the production achieved.
• Responsible for preparation of production planning on monthly and daily as per the requirement and availability of materials.
• Responsible for the handling of change control, deviations, CAPA, investigation etc.
• Responsible for document management like BMRs, BPRs, master SOPs etc..
• Responsible for preparation and review of protocols and reports based on the requirements.
• Responsible for preparation and review of protocols and reports based on the requirements.
• Responsible for preparation, review, revision, control, and implementation of standard operating procedures of sterile manufacturing department.
• Responsible for line clearance activity before commencing the operations like manufacturing, Sterilization, filling etc..
• Responsible to check that all the records and logbooks related to manufacturing, filling, garment washing and drying & sterilization of equipment’s .

Skills

• Adhering to Good Manufacturing Practices (GMP) and regulatory norms (USFDA, EU, WHO).
• Completing BMRs/BPRs accurately.
• Understanding of deviations, change control, and CAPA.
• Performing efficient changeovers between different products, batch sizes, or formats.
• Installing and adjusting forming/sealing materials, dies, and feeders.
• Understanding of tooling parts for blisters, bottles, and cartons

Qualifications

• ITI / B.Sc / Diploma