Executive - Aseptic Area Supervisor

Alembic Pharmaceuticals Limited; Vadodara; On-site; INR 450,000 - 750,000; Full time

Job summary

Alembic Pharmaceuticals Limited in Vadodara seeks a manufacturing professional to follow GMP/GDP and SOPs to ensure quality drug production. You will maintain hygiene, calibrate equipment, and support equipment qualification activities across autoclave, filling and process steps.

The role includes preparing master production documents, reviewing URS/QRM, and coordinating with MS&T for product transfers and scale-up batches, with involvement in inspections and regulatory audits.

Responsibilities

• To perform all the activities outlined in SOP.
• Follow online documentation as per GMP and GDP.
• Responsible for producing Quality drug Product.
• Maintain personnel hygiene and area gowning procedure.
• Monitor and keep equipment/instruments in validated and calibrated state.
• Follow the written procedures and understood the materials transfer philosophy.
• Maintain discipline in the department & coordination with cross functional team members.
• Preparation and review of DQ, IQ, OQ and PQ of all manufacturing equipment.
• Coordinate with MS&T for product transfer and execution of scale up and registration batches.
• Execute the Autoclave, Manufacturing and filling related activities.
• Prepare SOPs and other master documents of production.
• Prepare and review trends, URS and QRM documents.
• Participate in production equipment Installation, Commissioning and Qualification activities.
• Conduct FAT and SAT of production equipment.
• Execute Scale-Up, Exhibit, Commercial and Engineering run Batches.
• Ensure all equipment and lines are in qualified state.
• Audit Compliance
• Handling of regulatory audit

Job description

Role & responsibilities

• To perform all the activities outlined in SOP.
• Follow online documentation as per Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Responsible for producing Quality drug Product.
• To maintain personnel hygiene and discipline and area gowning procedure.
• To monitor and keep all equipment/ instruments in validated and calibrated state.
• To follow the written procedures and understood the materials transfer philosophy,

• To maintain the discipline in the department & Co- ordination with cross functional team members.
• Preparation and review of DQ, IQ, OQ and PQ of all the manufacturing equipment.
• Coordinate with MS&T for product transfer and execution of scale up and registration batches.
• To execute the Autoclave, Manufacturing and filling related activities.
• Preparation of SOPs and other master documents of production.
• To prepare and review trends, URS and QRM documents.
• To participate in production equipment Installation, Commissioning and Qualification activities.
• To conduct FAT and SAT of production equipment.
• To execute Scale-Up, Exhibit, Commercial and Engineering run Batches.
• Responsible to ensure that all equipment and lines are in qualified state.
• Audit Compliance
• Handling of regulatory audit