Officer - Manufacturing Area

USV PRIVATE LIMITED; Gujarat; On-site; INR 300,000 - 600,000; Full time

Job summary

USV PRIVATE LIMITED in Gujarat seeks a Production Operator to execute batch granulation daily, operate RMG, FBD, Roll Compactors, Multi-Mills and Vibro Sifters, and monitor parameters.

You will perform in-process quality checks, ensure cGMP compliance, maintain GDP batch documentation, cleanrooms, line clearance, and assist QA/QC and audit readiness to sustain production flow.

Qualifications

Responsibilities

• Execute daily granulation batches per SOPs and BMR.
• Operate RMG, FBD, Roll Compactors, Multi-Mills, Vibro Sifters.
• Monitor mixing time, binder rates, drying temps, moisture, granule size.
• Perform in-process checks: LOD, bulk density, particle size.
• Maintain cGMP, hygiene and EHS compliance.
• Complete batch docs, logbooks, and yield per GDP.
• Cleanroom and equipment sanitation; line clearance to prevent cross-contamination.
• Troubleshoot equipment issues; coordinate with maintenance/QA.
• Handle APIs/excipients per formulation cards.
• Support internal/external audits with QA/QC teams.

Skills

Batch production execution

Equipment operation

Process parameter monitoring

In-process quality checks

cGMP compliance

Batch documentation

Cleanroom & maintenance

Troubleshooting & optimization

Raw material handling

QA collaboration

Job description

• Batch Production Execution: Execute daily granulation batches according to standard operating procedures (SOPs) and Batch Manufacturing Records (BMR).
• Equipment Operation: Operate specialized processing machinery, including Rapid Mixer Granulators (RMG), Fluid Bed Dryers (FBD), Roll Compactors, Multi-Mills, and Vibro Sifters.
• Process Parameter Monitoring: Monitor critical parameters such as mixing time, binder spray rates, drying temperatures, moisture content, and granule size distribution.
• In-Process Quality Checks: Perform regular checks (e.g., loss on drying [LOD], bulk density, particle size analysis) to ensure products meet stringent quality specifications.
• cGMP Compliance: Maintain strict compliance with current Good Manufacturing Practices (cGMP), hygiene protocols, and environmental health and safety (EHS) guidelines.
• Batch Documentation: Accurately complete batch documentation, logbooks, and yield calculations following Good Documentation Practices (GDP).
• Cleanroom & Equipment Maintenance: Ensure proper cleaning, sanitation, and line clearance of granulation suites and machinery to prevent cross-contamination between batches.
• Troubleshooting & Optimization: Identify equipment malfunctions or process deviations early and coordinate with maintenance or Quality Assurance (QA) teams for swift resolution.
• Raw Material Handling: Verify and handle active pharmaceutical ingredients (APIs) and excipients according to exact formulation cards.
• Team & Audit Support: Assist in internal/external regulatory audits and collaborate with QA, QC, and downstream compression/encapsulation teams to maintain steady production flow.