Executive, Manufacturing Process Operations

Role Overview

Manufacturing Operations

• Operate reactors, centrifuges, dryers, mills, sifters, autoclaves, ovens, stills, and filtration equipment.
• Execute batch processing accurately and on time according to SOPs, BMR, BCR, BPR, and equipment usage logs.
• Mix and blend ingredients for pharmaceutical liquid products, suspensions, ointments, and other dosage forms.
• Monitor process parameters and maintain them within product specifications and quality requirements.
• Verify equipment cleanliness before charging batches and maintain housekeeping in manufacturing areas.
• Support equipment cleaning, maintenance, and general maintenance of pumps, homogenizers, filter presses, and tablet compression machines.

Documentation and Systems

• Maintain batch manufacturing, cleaning, packing, equipment-use, deviation, and online records legibly and completely.
• Review executed manufacturing documents, including BMR, BCR, and BPR records.
• Perform ERP and SAP activities for BOM, routing, and batch-level stock of raw materials, intermediates, and finished products.
• Prepare, revise, and review peptide and API product documents based on R&D processes.
• Implement E-log and SAP processes within the manufacturing department.

Quality and Materials

• Receive, store, handle, reconcile, and follow material-handling procedures for raw materials, intermediates, and finished products.
• Sample and test raw materials, intermediates, and finished products to maintain product quality and consistency.
• Monitor and record temperature, humidity, and differential pressure in clean areas.
• Check and record daily weighing-balance calibration and verification.
• Coordinate with QA for document issuance and submission and with warehouse teams for material issuance and submission.

Safety and Improvement

• Follow safety procedures, use PPE, and respond to spills, leaks, and safety incidents using established emergency procedures.
• Comply with environmental regulations, hazardous-material procedures, and waste-disposal requirements.
• Identify deviations, equipment malfunctions, and product-quality variations and address or escalate issues.
• Identify process optimization, efficiency improvement, and waste-reduction opportunities.
• Participate in training related to API and intermediate manufacturing and safety.

Education and Experience

• B.Pharm is required.
• M.Pharm is preferred.
• 5–8 years of relevant experience is required.

Compliance Requirements

• Execute SOPs in full compliance with cGMP, internal quality standards, and regulatory requirements.
• Ensure manufacturing activities comply with applicable FDA and EMA guidelines.