Executive

Manufacturing Oversight

• Monitor manufacturing activities to ensure compliance with cGMP and approved procedures.
• Perform line clearance before the start of production and after product changeover.
• Verify equipment cleanliness and status labeling.
• Ensure adherence to approved Batch Manufacturing Records (BMRs) and SOPs.

In-Process Quality Checks

• Perform and document in-process checks as per approved procedures.
• Verify dispensing, weighing, sampling, and material reconciliation activities.
• Monitor environmental conditions during manufacturing.
• Ensure critical process parameters are maintained within specified limits.

Documentation Review

• Review Batch Manufacturing Records (BMRs).
• Review Batch Packing Records (BPRs), where applicable.
• Verify Good Documentation Practices (GDP).
• Ensure accurate and complete documentation during production activities.

Compliance & GMP

• Ensure compliance with cGMP, GLP, GDP, and data integrity requirements.
• Identify GMP deficiencies and initiate corrective actions.
• Report quality events, deviations, and non-conformances.
• Participate in investigations, CAPA implementation, and effectiveness checks.

Sampling & Material Verification

• Verify raw materials and packaging materials before use.
• Perform in-process and finished product sampling as per SOPs.
• Ensure correct labeling and status identification of materials.

Audits & Inspections

• Support internal, customer, and regulatory audits.
• Participate in self-inspections and GMP walkthroughs.
• Ensure audit observations are addressed promptly.

Training

• Conduct GMP awareness programs.
• Train manufacturing personnel on quality systems and SOP compliance.
• Maintain training records.