Key Responsibilities
Manufacturing Operations
- Perform dispensing, sifting, mixing, homogenization, emulsification, and manufacturing activities as per approved BMRs and SOPs.
- Operate manufacturing equipment such as mixers, homogenizers, planetary mixers, manufacturing vessels, transfer pumps, and storage tanks.
- Execute batch manufacturing activities within scheduled timelines.
- Monitor and control process parameters such as temperature, mixing speed, pressure, vacuum, and processing time.
- Carry out batch charging and material addition activities as per manufacturing instructions.
- Perform product transfers between manufacturing vessels and holding tanks.
- Support scale-up and technology transfer batches when required.
Equipment Operation & Maintenance
- Perform equipment preparation, assembly, dismantling, and cleaning activities.
- Conduct pre-operation checks and ensure equipment is fit for use before manufacturing.
- Record equipment usage in logbooks.
- Identify equipment abnormalities and report them to supervisors and engineering teams.
- Support preventive maintenance and equipment qualification activities.
GMP & Documentation
- Complete manufacturing records accurately and contemporaneously.
- Maintain BMRs, equipment logbooks, cleaning records, and area checklists.
- Follow Good Documentation Practices (GDP) at all times.
- Report deviations, incidents, and non-conformances immediately.
- Participate in investigations and CAPA implementation activities.
Quality Compliance
- Ensure adherence to current Good Manufacturing Practices (cGMP).
- Follow approved SOPs, specifications, and manufacturing procedures.
- Perform line clearance verification before and after batch activities.
- Ensure no mix-ups, contamination, or cross-contamination occur during production.
- Support QA during in-process checks and audits.
- Maintain batch traceability throughout manufacturing operations.
Cleaning & Hygiene
- Perform cleaning and sanitization of manufacturing equipment and production areas.
- Follow cleaning validation requirements and cleaning procedures.
- Ensure manufacturing areas are maintained in a clean and inspection-ready condition.
- Dispose of waste materials as per approved procedures.
Safety, Health & Environment
- Follow EHS policies and safe work practices.
- Use required PPE during manufacturing activities.
- Report unsafe conditions, near misses, and safety incidents.
- Participate in safety observations, risk assessments, and emergency response activities.
- Handle chemicals, active ingredients, and cleaning agents safely.
Productivity & Continuous Improvement
- Minimize process losses and material wastage.
- Support Lean, Operational Excellence, and Continuous Improvement initiatives.
- Participate in Kaizen, 5S, and productivity improvement projects.
- Contribute ideas to improve process efficiency, quality, and safety.
Audit & Inspection Readiness
- Maintain production areas in a state of audit readiness.
- Support internal, customer, and regulatory audits.
- Demonstrate process and documentation knowledge during inspections.
- Ensure compliance with USFDA, MHRA, EU GMP, WHO GMP, and other applicable regulatory requirements.
Educational Qualification
Essential
- Diploma in Mechanical Engineering, or related discipline.
Experience
3-6 Years
